| HS Code | 716446 |
| Productname | Valens™ AH 2.0 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Brand | Valens™ |
| Model | AH 2.0 |
| Grade | Pharma Grade |
| Type | Active Pharmaceutical Ingredient (API) |
| Dosageforms | Tablet, Capsule, Granule, Injection |
| Routesofadministration | Oral, Injectable |
| Application | Pharmaceutical manufacturing |
| Manufacturer | Valens |
As an accredited Valens™ AH 2.0 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
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In direct compression of Valens™ AH 2.0 into 10 mm round bisect tablets, incoming lot characteristics define whether a pre-mill step is required. When the supplied powder exhibits a bulk density below 0.30 g/mL or a tapped density above 0.45 g/mL, the Carr index usually exceeds 30%, and flow from a 30 L square stainless steel hopper becomes discontinuous. A 500 µm stainless steel sieve is installed at the charge port to remove agglomerates formed during storage above 25°C. The screened powder is transferred to a 150 L V-shell blender operated at 15 rpm for 18 min; fill volume is maintained between 50% and 60% of gross capacity to avoid dead zones at the shell walls. After blending of diluent-grade lactose monohydrate, microcrystalline cellulose, croscarmellose sodium and colloidal silicon dioxide, the active fraction is checked in 10 sampling locations. A relative standard deviation below 2.0% is required before lubrication. Magnesium stearate is added at 0.5% w/w and mixed for 3 min; mixing beyond 5 min reduces tablet hardness below 50 N. The final blend is discharged through a 1.0 mm conical screen. On a 10-station rotary tablet press using B tooling and a paddle feeder, main compression force is held between 8 kN and 14 kN, precompression at 2 kN to 4 kN, and compression dwell time between 25 ms and 35 ms. Tablet hardness is targeted at 60 N to 90 N, friability is maintained below 0.5% after 100 rotations according to USP <1216>, and disintegration is controlled below 15 min per USP <701>. Dissolution sampling at 15 min, 30 min and 45 min follows USP <711>; product monograph Q-values rather than a universal release point determine pass/fail. Ejection force above 1,500 N indicates inadequate lubrication or punch wear; values below 800 N typically accompany low die fill and weight variability. Flow function coefficient measured by ring shear per ASTM D6773 should remain above 4.0; if ffc falls below 3.5, direct compression is abandoned and a granulation route is selected.
Pre-dispersion of Valens™ AH 2.0 in purified water at 20°C to 25°C is followed by binder addition into a 65 L top-drive high-shear mixer. A pregelatinized starch binder is prepared at 4.0% w/w solids with viscosity between 200 mPa·s and 800 mPa·s at 25°C; viscosities above 1,000 mPa·s produce oversized agglomerates that survive subsequent drying and cause content uniformity failures under USP <905>. Binder solution is added at 0.3 kg/min to 0.6 kg/min with the impeller running at 280 rpm and the chopper at 1,800 rpm. The endpoint is identified when impeller torque rises from a dry-mix baseline of 4 Nm to 9 Nm; power-consumption curves on the same mixer show that torque above 12 Nm corresponds to wet mass density above 0.75 g/mL and poor drying. The wet mass is passed through a 1.0 mm comill and dried in a fluid-bed dryer with inlet air at 60°C to 65°C and product temperature held at 32°C to 38°C. If product temperature exceeds 40°C during the first 10 min, granule friability increases and the compressed tablet capping rate rises above 2.0%. Drying is stopped at loss-on-drying of 1.5% to 2.0% because overdrying below 1.0% produces fines above 30% w/w and reduces tablet hardness. The dried granules are milled again through a 0.8 mm screen and a particle size distribution is checked by laser diffraction per USP <786>. The fraction between 125 µm and 850 µm should account for at least 85% w/w; oversized fraction above 850 µm above 10% w/w indicates that binder viscosity or chopper speed was too low to control agglomerate size. Granules are then lubricated with sodium stearyl fumarate at 0.75% w/w when magnesium stearate is incompatible with the API. Tablets are compressed at 10 kN to 16 kN on a 16-station rotary press; hardness is controlled between 80 N and 120 N, friability below 0.3%, and disintegration below 12 min per USP <701>.
In low-dose capsule filling of Valens™ AH 2.0 at 2.5 mg dose fractions, ordered mixing on a coarse lactose monohydrate carrier with D50 between 90 µm and 125 µm is adopted to prevent segregation. Carrier surface roughness and surface-bound fine lactose are controlled because these influence the attachment of micronized API particles. The API is sieved through a 150 µm screen and pre-blended with carrier for 15 min in a 50 L bin blender at 12 rpm. Total dilution ratios between 1:40 and 1:100 are typical; ratios above 1:150 increase the probability of content uniformity outliers under USP <905>. A dosator-type capsule filling machine operating at 100,000 capsules/h is used with powder bed height between 30 mm and 40 mm and tamping pin settings between 6 mm and 10 mm. Fill weight relative standard deviation below 2.0% is achieved when the powder bed is maintained at 40% to 55% relative humidity; below 30% RH electrostatic charging causes powder adhesion to acrylic surfaces and weight drift. Size 3 or 4 hard capsules are filled with total fill weight between 180 mg and 220 mg. In-process weight checks are performed every 30 min per FDA 21 CFR 211.110; automatic checkweighers reject capsules with weight deviation above 3.0%. Dissolution of immediate-release capsules is tested per USP <711>; storage above 40°C accelerates gelatin cross-linking and can delay release, so accelerated stability protocols per ICH Q1A(R2) include dissolution at 3 months and 6 months. Moisture ingress below 50% RH is controlled by HDPE bottles with desiccant or aluminum/aluminum blister packs.
Valens™ AH 2.0 blends with moisture content above 1.5% are not suitable for roller compaction because water activity above 0.50 promotes sticking to the roll surface. A dry blend is fed into a roller compactor with 150 mm serrated rolls at a roll speed of 5 rpm to 10 rpm and feed screw speed of 20 rpm to 40 rpm. Specific roll force is maintained between 6 kN/cm and 10 kN/cm and roll gap between 2.0 mm and 2.8 mm. Ribbon density is measured by helium pycnometry and should fall between 1.05 g/cm³ and 1.25 g/cm³. Ribbons below 1.00 g/cm³ are friable and generate fines exceeding 35% w/w after milling; ribbons above 1.30 g/cm³ are over-compacted, produce hard granules, and delay disintegration beyond 20 min unless an extragranular superdisintegrant is included. Roll surface temperature is held below 30°C; excursions above 35°C soften low-melting binders and create glassy granule shells with reduced porosity. The ribbon is milled through a 1.0 mm screen and classified. The post-mill granule fraction between 180 µm and 710 µm should be at least 70% w/w. Dry granulation is chosen when direct compression is limited by poor flow or moisture sensitivity; published data for this specific configuration is limited for terminal dissolution, so dissolution comparison between dry-granulated and direct-compressed tablets should be generated per USP <711> during scale-up. Tablets compressed from dry granulation typically require main compression force of 10 kN to 16 kN; hardness target is 70 N to 110 N, friability below 0.5%, and disintegration below 15 min. Croscarmellose sodium at 2.0% w/w to 4.0% w/w is added extragranularly to preserve disintegration performance.
Compounding of Valens™ AH 2.0 into a parenteral solution begins with dissolution in Water for Injection at 20°C to 25°C. If oxygen sensitivity is known from forced degradation, nitrogen overlay is applied during dissolution and holding. pH is adjusted with 0.1 N hydrochloric acid or sodium hydroxide to a target range of 5.5 to 6.5; the selected range is dictated by the API’s pH-rate profile, not by an arbitrary formulation rule. Buffer capacity is kept low to avoid injection pain and to minimize salt content. Osmolarity is adjusted with mannitol or dextrose to 280 mOsm/kg to 320 mOsm/kg measured by freezing point depression. The solution is filtered through a 0.22 µm PVDF membrane; filter integrity is verified by bubble point per the membrane manufacturer’s technical bulletin. Filling is performed by a stainless steel rotary piston pump with fill volume overage of 0.1 mL to 0.2 mL per vial to meet USP <1151> withdrawal requirements. The filled vials are partially stoppered and loaded onto a lyophilizer shelf pre-cooled to 5°C. The shelf is ramped to -45°C at 0.5°C/min and held for 2 h to ensure complete solidification. Primary drying is conducted at shelf temperature -25°C and chamber pressure 50 Pa for 48 h; the product temperature is kept below the collapse temperature of the formulation, which is determined by freeze-drying microscopy. Secondary drying is performed at 25°C and 10 Pa to 20 Pa for 6 h to 12 h until Karl Fischer titration shows residual moisture below 1.0% w/w per USP <921>. Cakes with residual moisture above 1.5% exhibit shrinkage, melt-back or long reconstitution times. Reconstitution time at 25°C is specified as below 3 min with gentle swirl. Sub-visible particulate matter is tested per USP <788>; the small-volume injection limits are not more than 6000 particles per container at ≥10 µm and not more than 600 particles per container at ≥25 µm. Visible particulates are assessed per USP <790>, sterility per USP <71>, and bacterial endotoxins per USP <85>. In the absence of a monograph limit for this API, an internal endotoxin limit of 0.5 EU/mg is applied based on dose-dependent endotoxin limits. Container closure integrity is verified by dye ingress or vacuum decay per USP <1207>. Aseptic processing uses unidirectional airflow under EU GMP Annex 1 and FDA 21 CFR 211.67; media-fill qualification is required before commercial batches.
| Attribute | Method | Acceptance criterion |
|---|---|---|
| Residual moisture | Karl Fischer USP <921> | <1.0% w/w |
| Sub-visible particulate matter | USP <788> | ≤6000 particles/vial ≥10 µm; ≤600 particles/vial ≥25 µm |
| Bacterial endotoxins | USP <85> | 0.5 EU/mg if monograph absent |
| Sterility | USP <71> | No growth at 14 days |
| Reconstitution time | Manual swirl at 25°C | <3 min |
Top-spray fluid-bed granulation of Valens™ AH 2.0 onto a mannitol-maltodextrin substrate requires binder solution viscosity below 200 mPa·s at 25°C to prevent nozzle blockage. A two-fluid nozzle with atomization air pressure between 1.5 bar and 2.5 bar is installed in a 50 L product bowl. Inlet air is controlled at 55°C to 70°C; product temperature is kept at 30°C to 38°C. Spray rate is maintained between 20 g/min and 40 g/min per kg substrate; rates above 50 g/min produce local overwetting and agglomeration defects. Bulk density is targeted between 0.45 g/mL and 0.60 g/mL. If bulk density falls below 0.40 g/mL, stick-pack fill volume exceeds package dimensions at 2 g doses; if bulk density exceeds 0.65 g/mL, the granules do not redisperse within 60 s in 100 mL water at 25°C. Redispersion testing uses a folding paddle stirrer at 50 rpm; the endpoint is the absence of visible granules and sediment. Residual moisture is maintained below 2.0% by Karl Fischer titration; residual organic solvents are tested by gas chromatography per USP <467> and must comply with ICH Q3C Class 3 limits. Sachet filling on a vertical stick-pack machine at 60 packs/min achieves fill weight relative standard deviation below 1.5% if the granulate has good flow and a Hausner ratio below 1.25. Packaging includes a desiccant when the formulation shows moisture uptake above 1.0% at 60% RH during 24 h; this is determined by dynamic vapor sorption. The granulation process is not accepted if the percentage of fines below 75 µm exceeds 10% w/w because fines segregate during filling and create weight variability.
| Parameter | Target range | Method / equipment |
|---|---|---|
| Binder solution viscosity at 25°C | 200 mPa·s max | Brookfield rotational viscometer |
| Atomization air pressure | 1.5 bar to 2.5 bar | Two-fluid nozzle |
| Product temperature | 30°C to 38°C | In-bed thermocouple |
| Bulk density | 0.45 g/mL to 0.60 g/mL | USP <616> |
| Residual moisture | <2.0% w/w | Karl Fischer USP <921> |
| Redispersion time | <60 s | Paddle stirrer 50 rpm |
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Valens™ AH 2.0 is released as a pharmaceutical-grade active pharmaceutical ingredient for tablet, capsule, granule, and injectable manufacturing under oral and parenteral administration routes. The product code AH 2.0 identifies a particle-engineered grade, distinct from unprocessed API and from technical intermediates, with release documentation that includes assay, related substances, residual solvents, elemental impurities, polymorph identity, particle-size distribution, bulk and tapped density, loss on drying, and, for injectable applications, bacterial endotoxin and bioburden. The material is manufactured under current good manufacturing practice as described in 21 CFR Parts 210 and 211, with batch-specific certificates of analysis and a Type II drug master file available to support regulatory submissions. Where compendial monographs exist for the active moiety, the acceptance criteria are aligned with Ph. Eur. and USP general chapters; where no monograph exists, the manufacturer’s validated in-house methods are used.
The product is not a formulation premix and is not released as a sterile API. Excipient compatibility, blend uniformity, finished-product stability, sterilization validation, and container-closure integrity remain the responsibility of the downstream dosage-form manufacturer. However, the grade is designed so that its physical attributes align with the unit operations most commonly used in oral solid dosage and injectable lines: direct compression, roller compaction, high-shear and fluid-bed granulation, dry blending, encapsulation, and dissolution into aqueous injection vehicles. For each of these operations, the product specification includes either a compendial test or a validated in-house method that provides a measurable input for process control.
Particle-size distribution is controlled by laser diffraction using USP <429> and Ph. Eur. 2.9.31. The batch-specific specification defines D10, D50, and D90 limits that are compatible with direct compression and dry granulation; the D90 upper limit is narrower than that typical of unprocessed crystallized material. The grade is not micronized by default unless a micronized option is selected, because uncontrolled micronization can increase surface energy, reduce bulk density, and amplify cohesive adhesion to tablet tooling. For AH 2.0, the manufacturer controls primary particle morphology through crystallization and post-crystallization delumping rather than relying solely on size reduction. This approach reduces the fraction of fine particles below 10 µm while maintaining a surface area that is within the specification for dissolution performance.
Bulk and tapped densities are measured according to USP <616> and Ph. Eur. 2.9.34. Powder flow is further characterized by USP <1174> using a shear cell or flow through an orifice. The supplier reports Carr index and Hausner ratio on each certificate of analysis; these values allow the downstream formulator to select direct compression, roller compaction, or wet granulation without additional re-milling. In addition, specific surface area is measured by nitrogen adsorption according to Ph. Eur. 2.9.26. The surface area specification is set to balance dissolution rate against cohesive handling behavior. Published data for the specific surface area of AH 2.0 is limited outside the supplier dossier; the batch-specific value should be requested before finalizing a dry powder inhalation or low-dose direct compression development program.
During capsule filling, the API is typically preblended with lactose monohydrate or microcrystalline cellulose and then encapsulated on a dosator or tamping-pin machine. The particle-size range of AH 2.0 is intended to reduce segregation in low-fill-weight formulations, but segregation must be verified by blend uniformity sampling per 21 CFR 211.110. For formulations with a target fill weight below 100 mg, stratified blend sampling and finished-capsule content uniformity per USP <905> are required before process validation. The product is compatible with hard gelatin and hypromellose capsules; however, moisture-sensitive formulations require desiccant protection because the API may contribute residual moisture. Dissolution of capsules containing AH 2.0 should be tested according to USP <711> or Ph. Eur. 2.9.3 using the basket or paddle apparatus specified in the dossier.
On high-speed rotary tablet presses, ejection force and die-wall lubrication are affected by the particle-size tail, not only by the median size. AH 2.0 is released with a controlled D90 and a controlled fines fraction to reduce ejection force variation when magnesium stearate is used at concentrations from 0.5% w/w to 1.5% w/w. The product is not lubricated at release; the formulator must add lubricant. Prolonged blending with magnesium stearate above 5 minutes at high shear can over-lubricate the formulation and reduce tablet tensile strength. In development batches, compaction profiles should be generated at compression pressures from 80 MPa to 220 MPa using a production-scale instrumented rotary press, for example a 47-station press operating at 60 rpm to 80 rpm. The resulting compactibility data should be interpreted with the tablet tensile strength measured according to USP <1217>.
Tablets containing AH 2.0 should be evaluated for capping and lamination at press speeds above 60 rpm because the particle surface may require a binder in direct compression. If excessive ejection force is observed, the formulator may reduce lubricant concentration or add a glidant such as colloidal silicon dioxide in the range of 0.1% w/w to 0.5% w/w. Tablet breaking force, friability, disintegration, and dissolution are measured according to USP <1217>, USP <1216>, USP <701>, and USP <711> respectively. The disintegration test is performed in purified water at 37 °C; acceptance follows the compendial monograph or the validated finished-product specification.
Roller compaction is used when direct compression is not feasible due to poor flow or high drug load. The material is blended with intragranular excipients, compacted at roll pressures typically between 4 kN/cm and 12 kN/cm, and milled to granules. AH 2.0’s controlled particle-size distribution reduces the need for aggressive pre-milling, but the downstream processor must control ribbon density variation across the roll width. Ribbon density is preferably measured by X-ray microcomputed tomography or mercury intrusion porosimetry to maintain consistent granule porosity. If the D90 is too high for a low-dose tablet, the product may be co-milled with a portion of the filler; this operation should be performed under nitrogen if the API is oxidation-sensitive. Milled granules should be re-tested for particle-size distribution using USP <429> to ensure that the fines fraction has not increased beyond the design space.
Wet granulation is applied when direct compression cannot deliver sufficient content uniformity or when the API requires improved wettability. The AH 2.0 grade is compatible with high-shear and fluid-bed granulation. In high-shear granulation, purified water is added at a rate of 2% w/w/min to 8% w/w/min until the target granule endpoint is reached; impeller speed and chopper speed are selected to avoid excessive fines generation. Loss on drying after drying is normally controlled between 1.0% and 2.5% for immediate-release formulations, but the exact limit is product-specific. The API is not hygroscopic in its primary packaging; however, exposure to ambient relative humidity above 60% during weighing and dispensing may require pre-drying or humidity-controlled suites. Granules containing AH 2.0 should be evaluated for residual moisture by USP <731> or Ph. Eur. 2.2.32 before compression.
In fluid-bed granulation, the binder solution is sprayed at a rate of 10 g/min/kg to 40 g/min/kg of dry mass with inlet air temperature controlled between 50 °C and 70 °C. The exhaust air temperature and product temperature are monitored to avoid overdrying, which can weaken granules and increase attrition. After granulation, the product is screened through a 0.8 mm to 1.25 mm mesh and lubricated. Granule flow through a tablet press hopper should be verified with a Flodex tester or an equivalent orifice-flow apparatus; the flow function coefficient should be above 4 for consistent die filling on high-speed presses. If the value falls below 4, glidant addition or granule size adjustment is required.
For injectable applications, the API is designated for oral and injectable use, but parenteral manufacturing requires additional controls beyond the oral solid dosage form. The injectable grade is released with bacterial endotoxin specified by USP <85> and Ph. Eur. 2.6.14; a typical limit for injectable-grade APIs may be set at 0.25 EU/mg or lower depending on the maximum daily dose. The manufacturer also reports bioburden and total aerobic microbial count according to USP <61> and USP <62>. The product is not sterile at release; terminal sterilization or aseptic filtration is the responsibility of the finished-product manufacturer. If the API is dissolved in water for injection and sterile-filtered through a 0.22 µm filter, particulate matter in the final solution must meet USP <788> for large-volume parenterals or USP <789> for small-volume parenterals. Incompatibility with certain buffer ions or pH extremes should be assessed under ICH Q8 design-of-experiment studies. The product should not be combined with strong oxidizing agents unless compatibility data exist.
For suspension injections, particle-size distribution becomes a critical quality attribute because oversized particles can cause capillary occlusion or poor syringeability. The injectable grade is therefore specified with a controlled D90 and a maximum particle-size limit, and the suspension is passed through a high-shear mixer or microfluidizer after compounding. Syringeability is tested using a texture analyzer or a syringe pump at a defined needle gauge, typically 21 G to 23 G. Sterilization by autoclaving at 121 °C for 15 minutes is common for heat-stable formulations; the thermal stability of AH 2.0 in the chosen pH and buffer system must be confirmed by forced degradation and thermal cycling studies. Terminal sterilization can change polymorphic form or increase related substances, so post-sterilization testing by HPLC and XRPD is required.
Each batch is released against a written specification that includes identity, assay, related substances, residual solvents, elemental impurities, water content, particle size, and endotoxin where applicable. The supplier’s drug master file contains validation reports, analytical method validation, stability data generated under ICH Q1A, and process validation data for three consecutive commercial-scale batches. The following table lists the primary release and regulatory controls; the acceptance criteria are specific to the regulatory dossier and may differ by market.
| Control area | Reference standard or method | Typical release commitment |
|---|---|---|
| Identity | USP <197> / Ph. Eur. 2.2.24; XRPD USP <941> | Conforms to reference spectrum |
| Assay | HPLC or UV per drug master file | 98.0–102.0% on dried basis |
| Related substances | HPLC | Individual unknown ≤ 0.10%; total ≤ 0.5% |
| Residual solvents | ICH Q3C Option 1 | Meets Class 1, Class 2, and Class 3 limits |
| Elemental impurities | ICH Q3D | Meets permitted daily exposure for relevant elements |
| Water content | USP <921> / Ph. Eur. 2.5.12 | ≤ 0.5% or dossier limit |
| Particle size | USP <429> / Ph. Eur. 2.9.31 | D90 ≤ dossier-specified limit |
| Bulk and tapped density | USP <616> / Ph. Eur. 2.9.34 | Report value |
| Bacterial endotoxin | USP <85> / Ph. Eur. 2.6.14 | ≤ dossier-specified injectable limit |
Stability data for the API are generated under ICH Q1A conditions: long-term 25 °C/60% RH, accelerated 40 °C/75% RH, and intermediate 30 °C/65% RH where required. The product is packaged in double low-density polyethylene bags inside a sealed aluminum foil pouch with desiccant. The manufacturer’s retest period is stated in the certificate of analysis. The API should be stored away from moisture and direct light. As an operational boundary, exposure to relative humidity above 60% during dispensing should be limited to less than 8 hours unless a qualified humidity-controlled suite is used. Avoid contact with strong acids, bases, and oxidizing agents.
Cleaning validation for shared equipment should include swab sampling after batches containing AH 2.0 because the API may adsorb to stainless steel surfaces. Analytical methods for swab samples should be validated for recovery from stainless steel and from contact materials used in the facility. Acceptable residue limits should be calculated from toxicity data and maximum daily dose in accordance with the site cleaning validation master plan. The product contains no intentionally added preservatives; it is not supplied with cleaning agents.
Shipment is performed at controlled ambient temperature, with temperature data loggers on request. The API is not classified as dangerous goods under standard transport regulations unless the safety data sheet indicates otherwise. For injectable use, containers should be opened in a Grade C or Grade D environment under conditions that minimize bioburden ingress; transfer to Grade A for aseptic operations is performed by the finished-product manufacturer.
AH 2.0 differs from technical-grade material by the absence of non-pharmaceutical crystallization solvents and by compliance with ICH Q3C and ICH Q3D. Compared with standard unengineered API, AH 2.0 is released with tighter particle-size distribution, a defined fines fraction, and injectable-grade endotoxin documentation when the injectable option is selected. The following table summarizes the principal differences.
| Parameter | Valens AH 2.0 Pharma Grade | Technical or unengineered grade |
|---|---|---|
| Regulatory status | cGMP, 21 CFR 210/211, Type II drug master file | May be non-cGMP |
| Residual solvents | ICH Q3C Option 1 | Not controlled |
| Elemental impurities | ICH Q3D | Not controlled |
| Bacterial endotoxin | Injectable option tested per USP <85> | Not tested |
| Particle size | Controlled D10/D50/D90 by USP <429> | Variable or uncontrolled |
| Polymorph identity | XRPD by USP <941> | Not controlled |
| Documentation | Certificate of analysis, stability data, drug master file | Limited |
On production-scale tablet lines, the most common failure mode associated with poorly controlled API particle size is sticking to punch faces at compression forces above 15 kN. With AH 2.0, sticking can still occur if the formulation contains hygroscopic fillers or if the tableting environment exceeds 55% RH. The product should therefore be evaluated in a pilot batch at the intended press speed, compression force, and tooling configuration before commercial scale-up. For injectable lines, the API should be dissolved or suspended in a closed vessel under nitrogen if oxidation-sensitive; terminal sterilization by autoclaving at 121 °C should be confirmed by thermal cycling studies because the API may degrade if pH is outside the stable range. The operational limits for pH and temperature are specific to the active moiety and must be obtained from the supplier’s stability and compatibility documentation rather than inferred from oral formulation performance.
