Azithromycin EC capsules Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable
- Product Name: Azithromycin EC capsules Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable
- Factroy Site: Yudu County, Ganzhou, Jiangxi, China
- Price Inquiry: sales10@sinochem-nanjing.com
- Manufacturer: Ascent Petrochem Holdings Co., Limited
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- Azithromycin EC capsules Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is typically used in formulations when enteric-release pH, particle size distribution, and polymorphic purity and moisture content, processing temperature, and mechanical shear must be controlled within specific ranges.
| HS Code | 579394 |
| Product Name | Azithromycin EC capsules Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Api Name | Azithromycin |
| Pharma Grade | Pharma Grade / API Grade |
| Dosage Forms | Tablet, Capsule, Granule, Injection |
| Routes Of Administration | Oral, Injectable |
| Cas Number | 83905-01-5 |
| Molecular Formula | C38H72N2O12 |
| Molecular Weight | 748.98 g/mol |
| Appearance | White to off-white crystalline powder |
| Solubility | Slightly soluble in water; soluble in ethanol, acetone, chloroform |
| Storage Condition | Store in a cool, dry place, protected from light |
| Shelf Life | 24 to 36 months when stored properly |
| Packaging | Fiber drum with double polyethylene bags |
| Therapeutic Class | Macrolide antibiotic |
| Mechanism Of Action | Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit |
| Assay | 95.0% to 102.0% |
| Pharmacopoeia Compliance | USP, EP, BP, IP |
As an accredited Azithromycin EC capsules 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.
| Packing | Azithromycin EC API supplied in 25 kg double-lined polyethylene bags inside fibre drums, sealed and labeled for pharma use. |
| Container Loading (20′ FCL) | 20′ FCL container loading: palletized, shrink-wrapped Azithromycin EC capsules, pharma-grade API, securely stowed for oral/injectable tablet, capsule, granule, injection use. |
| Shipping | Shipping Description: Azithromycin EC capsules Pharma Grade API for oral/injectable use is transported in sealed, tamper-evident, moisture-barrier containers under controlled ambient conditions (15–25°C), protected from light, heat, and humidity. GMP/ICH labeling and documentation accompany each shipment; temperature monitoring is used when required. Normally not regulated as dangerous goods. |
| Storage | Store Azithromycin EC capsules Pharma Grade API in tightly closed, original containers in a cool, dry, well-ventilated area away from direct sunlight. Protect from moisture, heat, light, and incompatible materials. Maintain controlled room temperature 20–25°C (68–77°F); permitted excursions 15–30°C. Do not freeze. Follow manufacturer and cGMP storage requirements for oral and injectable use. |
| Shelf Life | Azithromycin EC API Shelf Life: typically 24–36 months if stored dry, below 25°C, protected from light/moisture; verify via manufacturer’s COA. |
Roller compaction of azithromycin dihydrate is adopted when direct compression fails because the API has cohesive flow, low bulk density, and a tendency to stick to steel tooling at tablet press speeds above 40 rpm. On an Alexanderwerk WP 120 Pharma roller compactor with 250 mm diameter rolls and 25 mm knurled side seals, a blend containing azithromycin dihydrate equivalent to 250 mg base in a 400 mg core or 500 mg base in an 800 mg core is compacted at roll pressure 8–12 MPa, roll gap 2–4 mm, and screw feeder speed 20–40 rpm; the API mass fraction is held at 62.5% w/w as a development target, although published tablet core masses can range from 320 mg to 450 mg for the 250 mg strength, shifting the API fraction to 55–78% w/w. Ribbon density must remain between 1.0 g/cm³ and 1.3 g/cm³: below 1.0 g/cm³ fines below 150 µm exceed 25% w/w and cause capping, while above 1.3 g/cm³ the granules lose compactibility and tablet hardness falls below 60 N. The milled granules are screened through a 1.0 mm conical mill, blended with croscarmellose sodium 3.0% w/w, colloidal silicon dioxide 0.5% w/w, and magnesium stearate 0.75% w/w in a 600 L bin blender at 12 rpm for 15 min, then compressed on a Fette P2020 rotary press with 19.0 mm × 9.0 mm oval tooling. Film coating with Opadry II aqueous dispersion at 3.0% w/w weight gain is performed in a side-vented coating pan. Compliance is demonstrated by USP <905> uniformity of dosage units, USP <711> dissolution with product-specific medium, Ph. Eur. 2.9.5 uniformity of mass, USP <701> disintegration, and ICH Q3D(R2) elemental impurities. Terminal finished product type is immediate-release film-coated tablets used for respiratory tract, skin, and sexually transmitted infections; the same roller-compacted granulation can be split for 250 mg and 500 mg strengths to reduce process validation burden.
| Dosage form | API mass fraction | Unit dose | Critical processing limit | Primary release standard |
|---|---|---|---|---|
| Roller-compacted immediate-release tablet | 55–65% w/w | 250 mg / 500 mg | Ribbon density 1.0–1.3 g/cm³ | USP <711> |
| Powder for oral suspension | 4.0–8.0% w/w in dry powder | 100 mg/5 mL or 200 mg/5 mL | Granule LOD NMT 1.5% w/w | USP <698>, USP <905> |
| Enteric-coated multiparticulate capsule | 15–25% w/w on drug-layered pellets | 250 mg base per capsule | Acid-stage release NMT 10% in 2 h | USP <711> delayed-release |
| Lyophilized injection powder | 84–88% w/w in cake | 500 mg base per vial | Cake moisture NMT 3.0% w/w | USP <1>, USP <85> |
| Hard capsule powder fill | 55–70% w/w | 250 mg base per capsule | Fill room RH <40% | USP <905> |
What Limits Reconstitution Stability and Dose Homogeneity in Azithromycin Powder for Oral Suspension?
Azithromycin dihydrate for suspension is not a simple dry blend; the API has low aqueous solubility at neutral pH and tends to sediment within 10–15 min without a structured suspending matrix, so the dry powder must combine an insoluble drug fraction with a water-soluble buffer and a high-molecular-weight hydrocolloid. The dry powder is formulated to deliver 100 mg or 200 mg azithromycin base per 5 mL after reconstitution; for a 30 mL bottle with a dry fill mass of 12–18 g, the API mass fraction is 4.0–8.0% w/w. Wet granulation in a high-shear mixer uses sucrose at 82–88% w/w, sodium phosphate 2–4% w/w, hydroxypropyl cellulose 1–2% w/w, xanthan gum 0.1–0.3% w/w, and spray-dried flavor; purified water is added at 6–9% w/w, and the wet mass is dried in a fluid-bed dryer at inlet air temperature 45–55°C until loss on drying is NMT 1.5% w/w. The dried granules are milled through a 1.0 mm screen, blended, and filled into HDPE bottles with desiccant canisters under RH < 35%. In-process controls include sieve analysis and blend uniformity by near-infrared reflectance. Compliance requires USP <698> deliverable volume, USP <905> uniformity of dosage units, Ph. Eur. 2.9.5 and 2.9.3, and microbial quality per Ph. Eur. 2.6.12/2.6.13. The terminal finished product is a reconstituted oral suspension delivering 100 mg/5 mL or 200 mg/5 mL for pediatric and adult use; after reconstitution, viscosity should remain in the validated range of 150–350 mPa·s at 25°C to balance dose uniformity and pourability.
Enteric-coated multiparticulate azithromycin capsules are manufactured when the target product profile requires delayed release or reduced gastric exposure; however, published data for this specific azithromycin configuration is limited and immediate-release capsules dominate commercial supplies, so every enteric formulation must be justified through comparative dissolution testing in 0.1 N HCl for 2 h followed by phosphate buffer pH 6.8. The process begins with inert sugar spheres 710–850 µm layered with azithromycin dihydrate from an aqueous low-binder suspension in a bottom-spray Wurster fluid-bed coater; drug layering targets 15–25% w/w drug load on dried pellets. A subcoat of hypromellose 5–8% w/w weight gain is applied to prevent core erosion, followed by an acid-resistant coat of methacrylic acid-ethyl acrylate copolymer (Eudragit L 30 D-55) at 15–20% w/w polymer weight gain, with triethyl citrate 10–20% w/w related to polymer dry weight and talc 30–50% w/w related to polymer dry weight as anti-tacking agent. Coated pellets are dried at 40–45°C for 12–24 h, sieved to remove agglomerates above 1.18 mm, and filled into hard capsules to deliver 250 mg azithromycin base per unit; due to pellet density 1.2–1.4 g/cm³, a size 0 or size 00 capsule is generally required. Compliance is anchored to USP <711> delayed-release acceptance criteria, Ph. Eur. 2.9.3, USP <701> disintegration, and ICH Q3D(R2). Terminal finished product type is an enteric-coated multiparticulate capsule for clinical settings requiring delayed intestinal release; batch release should include acid-stage release NMT 10% after 2 h and buffer-stage release NLT 80% after 45 min, with individual pellet dissolution mapping used to detect coating failure.
Lyophilized azithromycin parenteral powder is buffered with citrate and filled aseptically after terminal filtration.
Parenteral azithromycin is supplied as a sterile lyophilized powder that is reconstituted to 100 mg/mL with Sterile Water for Injection and then diluted to 1–2 mg/mL in sodium chloride 0.9% w/v or dextrose 5% w/v for intravenous infusion over 1–3 h. Each 10 mL Type I borosilicate glass vial contains azithromycin dihydrate equivalent to 500 mg azithromycin base (524.5 mg dihydrate), anhydrous citric acid 77.6 mg, and sodium hydroxide q.s. to pH 6.4–6.8; the lyophilized cake mass is approximately 602 mg, placing the API mass fraction at 87% w/w on an as-is dihydrate basis. The compounding process dissolves the sterile API in Water for Injection at 10–15°C, adds citrate, adjusts pH with sodium hydroxide, and passes the solution through a 0.22 µm PVDF or PES sterilizing filter before filling into depyrogenated vials inside an isolator or restricted-access barrier system. The lyophilization cycle ramps the shelf from 5°C to −45°C at 0.5–1.0°C/min, holds primary drying at −25°C to −15°C with chamber pressure 200–400 mTorr, and applies secondary drying at 25°C for 6–10 h until cake water content is NMT 3.0% w/w; vials are backfilled with filtered nitrogen. Compliance is governed by USP <1> Injections, USP <71> sterility tests, USP <85> bacterial endotoxins test with product-specific limit derived from maximum adult daily dose, USP <921> water determination, Ph. Eur. 2.6.1, Ph. Eur. 2.6.14, and EU GMP Annex 1 for aseptic processing. Terminal finished product type is a single-dose lyophilized powder for IV infusion in community-acquired pneumonia, pelvic inflammatory disease, and severe outpatient infections; visible particulate inspection follows USP <790>. The formulation is not intended for intramuscular or rapid IV bolus administration because the reconstituted solution is acidic before dilution and may cause injection-site pain.
When azithromycin dihydrate is filled into hard capsules, charge dissipation, lubricant level, and fill weight control define the operating window.
High-dose azithromycin hard capsule formulation begins with API having typical bulk density 0.25–0.45 g/cm³, tapped density 0.45–0.65 g/cm³, and Carr index 25–40, which requires glidant and lubricant addition to maintain fill weight RSD NMT 2.0% at 60,000 capsules/h on an MG2 Compact 12 or Bosch GKF 1500 encapsulator. The powder blend contains azithromycin dihydrate equivalent to 250 mg base per unit, with an API mass fraction of 55–70% w/w in a size 1 capsule; pregelatinized starch or lactose monohydrate is added at 20–30% w/w, croscarmellose sodium at 2–5% w/w, colloidal silicon dioxide at 0.5–1.5% w/w, and magnesium stearate at 0.5–1.0% w/w. Mixing is performed in a 300 L bin blender at 12 rpm for 15 min, with magnesium stearate added as a final 3 min pass to limit hydrophobic film formation on the API; over-lubrication above 1.0% w/w or mixing beyond 5 min can reduce dissolution below the product-specific acceptance criterion. The filled capsules are de-dusted, metal-checked, and sampled for in-process weight, lock length, and disintegration. Compliance requires USP <905>, USP <711>, Ph. Eur. 2.9.5 and 2.9.3, and 21 CFR 211.110 in-process sampling. Terminal finished product type is an immediate-release hard gelatin or HPMC capsule for adult oral therapy. The main processing boundary is relative humidity: above 40% RH the API becomes tacky and adheres to hopper walls, while below 20% RH triboelectric charge causes powder to stick to dosator pins and increases weight variation beyond 3.0% RSD.
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- Azithromycin EC capsules Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is manufactured under an ISO 9001 quality system and complies with relevant regulatory requirements.
- COA, SDS/MSDS, and related certificates are available upon request. For certificate requests or inquiries, contact: sales10@sinochem-nanjing.com.
Azithromycin EC Capsules Pharma Grade API is a compendial active pharmaceutical ingredient supplied for downstream formulation into enteric-coated capsules, tablets, granules, and injectable preparations. The material is azithromycin dihydrate, a white to off-white crystalline powder with a base molecular mass of 748.98 g/mol and a dihydrate molecular mass of 785.02 g/mol. The EC designation does not mean the material is a finished capsule; it denotes qualification for enteric-coated capsule processes, including pellet layering, enteric film application, and high-shear granulation. Compliance is established against Ph. Eur. 1649 and the current USP-NF Azithromycin monograph. Assay is determined by high-performance liquid chromatography and is controlled between 945 μg/mg and 1030 μg/mg on an anhydrous basis. The API is practically insoluble in water but soluble in ethanol, and its processing behavior is governed by particle-size distribution, crystalline form, residual solvent profile, and moisture content.
What Distinguishes Enteric-Coated Capsule Grade Azithromycin from Standard Oral Powder Grades?
The principal differences are physical and microbial rather than chemical. Enteric-coated capsule processing requires azithromycin dihydrate to remain thermally stable during aqueous or organic polymer coating and to resist crystal-form conversion during wet granulation. The dihydrate form is preferred because it is stable under ambient humidity and less likely to recrystallize during storage or aqueous polymer application. Residual solvents are controlled to ICH Q3C limits because ethanol and acetone residues can alter enteric film adhesion and create coating defects. Particle-size specification is tightened for capsule-grade material; powders intended for encapsulation are generally controlled at D90 ≤ 150 µm by laser diffraction, while granule grades for oral suspension often require D90 ≤ 20 µm for rapid redispersion. Standard oral powder without these physical controls may cause weight variation, pellet aggregation, and acid-stage release failures in delayed-release testing.
On production-scale high-shear granulators with working capacities from 100 L to 600 L, azithromycin dihydrate powder can segregate from filler particles if dry blending is prolonged. Observed batch-to-batch variation in capsule fill weight is reduced when the API is passed through a 30-mesh sieve before blending and when a glidant such as colloidal silicon dioxide is used at 0.5–1.0% w/w. The granulating fluid is added at 20–30% w/w of the dry powder mass. For direct compression, the powder exhibits low compactibility, and formulations typically require silicified microcrystalline cellulose and a dry binder. Granules are dried to a product-specific loss-on-drying endpoint, commonly ≤2.0% before encapsulation, to avoid capsule shell brittleness and enteric coating adhesion failure.
Particle Size, Polymorph Stability and Process Humidity
Particle-size distribution is measured by ISO 13320 laser diffraction, using dry dispersion unless static charge distorts the measurement. The milled dihydrate grade typically shows a span (D90−D10)/D50 below 2.5 to reduce segregation during transfer. X-ray powder diffraction is used to confirm the dihydrate pattern against the reference diffractogram. At 25 °C and 60% RH, the dihydrate maintains crystal water and acceptable flow. Open handling at 75% RH or above can increase surface moisture and reduce flowability, and pre-drying should be considered if moisture uptake exceeds the release limit. Contact surfaces are specified as 316L stainless steel because trace metal ions can accelerate oxidative degradation. Product is handled in closed transfer systems during milling and sieving to limit humidity excursions and particle attrition.
Residue on ignition and heavy metals are controlled according to the current compendial monograph and ICH Q3D elemental impurity requirements. Initial qualification includes XRPD, differential scanning calorimetry, Karl Fischer water determination, and Fourier-transform infrared spectroscopy. The water content of azithromycin dihydrate is a critical quality attribute because assay is reported on an anhydrous basis and excess moisture can reduce potency per unit mass. For enteric-coated capsule applications, water activity should be controlled by desiccant packaging and not merely by loss-on-drying release. Suppliers typically package the API in double food-grade polyethylene bags inside fiber drums, with desiccant and humidity indicator cards.
When Injectable-Grade Azithromycin Is Required in Aseptic Lines
Injectable-grade azithromycin differs from oral powder in microbial quality, endotoxin content, and subvisible particulate control. The API is released against a bacterial endotoxin limit appropriate to the parenteral product. Where a specific bulk API endotoxin limit is not stated in the compendial monograph, published data for this specific configuration is limited; the limit should be derived from the maximum adult daily dose and is product-specific. A typical control level for azithromycin parenteral use is ≤0.1 EU/mg when tested according to USP <85> or Ph. Eur. 2.6.14. Total aerobic microbial count before sterile processing is controlled to ≤10 CFU/g for injection-grade material. Because azithromycin is heat-sensitive, terminal sterilization is not always compatible; the finished injection is commonly produced by dissolving the API, sterile-filtering through a 0.22 µm membrane, and lyophilizing in vials. Sterility testing follows USP <71> and particulate matter in the reconstituted solution is measured under USP <788>.
Azithromycin for injection differs from enteric-coated capsule grade in three release parameters: endotoxin content, subvisible particulate count after reconstitution, and residual moisture of the lyophilized cake. The lyophilization cycle is formulation-specific, but primary drying generally holds the product shelf temperature below the collapse temperature, followed by secondary drying to produce a cake with low residual moisture. Without a bulking agent such as mannitol, low-dose vials may show cake collapse and increased reconstitution time. Filtration compatibility studies should include polyethersulfone and PVDF membranes because the API solution can exhibit adsorption on certain polymeric filters under low-dose conditions.
Aqueous Solubility and Dissolution Testing Are Bounded by Compendial Buffer Systems
The API is practically insoluble in water but displays pH-dependent solubility. Dissolution testing must therefore specify ionic strength and surfactant concentration; otherwise laboratory-to-laboratory variability is significant. For enteric-coated capsules, delayed-release testing requires acid-stage resistance for 2 h in 0.1 N hydrochloric acid at 37 ± 0.5 °C, followed by buffer-stage release in pH 6.8 phosphate buffer. Product-specific acceptance criteria commonly require not more than 10% release in the acid stage and not less than 80% release within 60 min after transfer to buffer. Immediate-release azithromycin products are tested under USP <711> using apparatus 2 at 50 rpm or apparatus 1 at 100 rpm depending on the dosage form. The dissolution medium is product-specific but generally contains phosphate buffer with a surfactant.
| Application Grade | Typical Particle-Size Control | Microbial / Endotoxin Release Criterion | Processing Route | Primary Standard / Test |
|---|---|---|---|---|
| Enteric-coated capsule / tablet oral grade | D90 ≤ 150 µm | TAMC ≤ 100 CFU/g, TYMC ≤ 20 CFU/g | Wet granulation, direct compression, pellet coating | Ph. Eur. 5.1.4, USP <711> |
| Granule for oral suspension | D90 ≤ 20 µm, span ≤ 2.5 | TAMC ≤ 100 CFU/g, TYMC ≤ 20 CFU/g | High-shear granulation, fluid-bed drying, taste-masked coating | ISO 13320, USP <711> |
| Injectable grade | Solution filtration at 0.22 µm | Endotoxin ≤ 0.1 EU/mg, sterility | Dissolution, sterile filtration, lyophilization | USP <71>, USP <85>, USP <788> |
Relative to erythromycin and clarithromycin, azithromycin is a 15-membered azalide in which a methyl-substituted nitrogen is incorporated into the lactone ring. This structural change reduces acid-catalyzed degradation and supports oral administration with better acid stability than erythromycin. For the API analyst, it also changes chromatographic retention times, infrared identification, and optical rotation. The dihydrate form contains crystal water that is not present in clarithromycin and must be considered when calculating assay results on an anhydrous basis. Substitution with non-compendial azithromycin powder may pass assay but fail related-substance testing due to unidentified peaks, elevated azithromycin N-oxide, or erythromycin-related impurities. Pharmacopoeial monographs set specified impurity limits, and any unidentified peak above the reporting threshold requires mass balance review before release.
Residual solvents are controlled to ICH Q3C classes. Ethanol and acetone are the most common residuals from recrystallization and drying. Enteric-coated capsule and pediatric granule grades may require lower residual solvent levels than ordinary oral powder because solvent vapors can be trapped in polymer films during coating and can affect taste perception in oral suspensions. Aqueous enteric dispersions require low residual alcohol to avoid film cracking and premature acid failure. In injectable applications, residual solvent limits are strictly aligned to the parenteral product license, and analytical methods are validated for gas chromatography with headspace sampling according to USP <467> or Ph. Eur. 2.4.24.
Non-compendial material also differs from the product described here in particle consistency and production scale. The pharmaceutical-grade API is manufactured under ICH Q7 good manufacturing practice for active pharmaceutical ingredients, with batch records covering recrystallization, milling, sieving, and packaging. Critical process parameters include crystallization temperature, cooling rate, and final drying temperature, all of which influence the dihydrate crystal habit and particle-size distribution. If the particle-size distribution is allowed to drift outside the qualified range, downstream enteric-coated pellet coating may show layer separation, capsule filling may fail uniformity limits, and reconstitution time for injectable product may increase. Batch release includes assay, related substances, water content, residual solvents, residue on ignition, heavy metals or elemental impurities, particle size where applicable, and microbial limits for non-sterile or sterile applications.
