Introduction
Cephalexin is a first-generation cephalosporin antibiotic widely used as an Active Pharmaceutical Ingredient (API) in oral antibacterial formulations. Its bactericidal activity is mediated by binding to penicillin-binding proteins (PBPs), thereby inhibiting bacterial cell wall synthesis and leading to cell lysis [1]. Cephalexin is acid-stable, rapidly absorbed after oral administration, and primarily excreted unchanged via the kidneys, making it suitable for convenient oral dosing regimens [2].
Cephalexin Powder (CAS 15686-71-2) supplied by Huilin is produced under strict GMP and ISO 9001 quality management systems. The product complies with major pharmacopeia standards and is available with full regulatory documentation, including batch-specific Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and Drug Master File (DMF) upon request. Consistent purity, low impurity profile, and flexible supply options make it a reliable choice for pharmaceutical manufacturers, contract development organizations, and veterinary product formulators worldwide.
Certificate of Analysis (COA)
| Parameter | Specification | Typical Result |
|---|---|---|
| Appearance | White to off-white crystalline powder | Complies |
| Assay (on dried basis) | 98.0% – 102.0% | 99.5% |
| Identification | Complies with USP/EP/BP reference standard | Complies |
| Related Substances | Total impurities ≤ 1.0% | 0.65% |
| Loss on Drying | ≤ 6.0% | 4.5% |
| Heavy Metals | ≤ 20 ppm | Complies |
| pH (1% aq. solution) | 4.0 – 6.0 | 5.2 |
| Specific Optical Rotation | +149° to +158° (on anhydrous basis) | +154° |
| Particle Size Distribution | As per customer specifications (micronized available) | D90 ≤ 180 µm |
| Residual Solvents | Meets ICH Q3C requirements | Complies |
| Microbial Limits | TAMC ≤ 1000 cfu/g; absence of specified pathogens | Complies |
Note: Batch-specific COA is available upon request.
Process Flow of Cephalexin
Cephalexin is produced via enzymatic synthesis using immobilized penicillin G acylase (IPGA). This route offers high yield, mild conditions, and reduced waste [4].
Key steps:
- Enzymatic reaction – 7‑ADCA and D‑phenylglycine methyl ester (PGME) are reacted in an aqueous medium using IPGA as a catalyst. Optimized conditions: 37 °C, pH 6.0 [2].
- Suspension system – Under optimized suspension conditions, up to 99.3% conversion of 7‑ADCA is achieved; IPGA retains 95.4% activity after 10 cycles [3].
- Isolation & purification – Crude product is filtered, recrystallized, and dried.
- Micronization (optional) – Custom particle size reduction.
- QC & packaging – Final testing per pharmacopeia standards, then packed in HDPE drums or foil bags.
The enzyme‑based process provides a sustainable and efficient manufacturing platform [4].
benefits
High Purity and Consistent Quality:
Our Cephalexin Powder meets or exceeds all major pharmacopeia standards, with typical purity ≥99%. Strict quality control systems and validated analytical methods ensure exceptional batch-to-batch consistency.
Eco-friendly Manufacturing Process:
The enzymatic synthesis using immobilized penicillin G acylase enables mild reaction conditions, minimal waste generation, and superior conversion rates (up to 99.3%), supporting sustainable pharmaceutical manufacturing practices [3].
Regulatory Compliance and Documentation:
Manufactured in GMP-certified and ISO 9001-compliant facilities. Complete regulatory documentation, including COA, MSDS, manufacturing license, and DMF, is available upon request to support global market registration.
Flexible Supply Chain:
MOQ as low as 1 kg enables sampling, R&D trials, pilot batches, and commercial-scale production. Lead times range from 7 to 60 days, depending on batch size, with strategic inventory management to ensure timely delivery.
Global Export Capability:
Our product can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. We work with verified logistics partners to ensure compliance with international shipping requirements.
Veterinary Suitability:
Suitable for both human pharmaceutical formulations and veterinary applications, subject to compliance with local regulatory requirements.
Cost-Effective Sourcing:
Competitive pricing achieved through direct manufacturing and an efficient supply chain, delivering exceptional value to pharmaceutical companies, distributors, and contract manufacturers worldwide.
Cephalexin uses
1. Pharmaceutical Applications (Human Medicine):
- Active Pharmaceutical Ingredient (API): Formulated into various oral dosage forms, including capsules (250 mg, 500 mg), tablets, and powder for oral suspension (125 mg/5 mL, 250 mg/5 mL) [1][2].
- Indications: Treatment of infections caused by susceptible strains of microorganisms, including:
Respiratory tract infections (pharyngitis, tonsillitis, pneumonia)
Urinary tract infections
Skin and soft tissue infections
Otitis media
Bone infections
- Prophylactic Use: To reduce the risk of certain surgical site infections [1].
- Pediatric Use: The powder for oral suspension formulation provides convenient and accurate dosing for pediatric patients who may have difficulty swallowing tablets [1].
2. Veterinary Applications:
- Companion Animals: Treatment of bacterial infections in dogs and cats, including skin infections caused by Staphylococcus pseudintermedius. Also used for urinary tract infections and other bacterial conditions under veterinary supervision.
- Food-producing Animals: Extralabel use of cephalosporins (including cephalexin) in cattle, swine, chickens, or turkeys is prohibited in the U.S. for disease prevention purposes, at unapproved doses, frequencies, durations, or routes of administration, or if the drug is not approved for that species and production class [5][6]. Customers must strictly follow local regulatory requirements when considering veterinary applications.
Note: All applications must comply with local regulatory requirements, including applicable approvals, prescriptions, and marketing authorizations.
Frequently Asked Questions (FAQ)
Q: What quality certifications does your Cephalexin Powder have?
A: Our Cephalexin Powder is manufactured in GMP-certified and ISO 9001-compliant facilities. The product meets major pharmacopeia standards. We provide complete quality documentation, including a COA for every batch, as well as MSDS, a manufacturing license, and a DMF upon request for qualified buyers.
Q: Do you provide samples for quality testing?
A: Yes, samples are available for quality evaluation and analytical testing. Please get in touch with our sales team to discuss the sample request procedure and any applicable charges. Sample quantities are typically 1 kg foil bags.
Q: Is this Cephalexin suitable for veterinary formulation?
A: Yes, our Cephalexin Powder is suitable for both human pharmaceutical and veterinary applications. However, veterinary use must strictly comply with local regulations. In the U.S., extralabel use of cephalosporins (including cephalexin) in cattle, swine, chickens, and turkeys is subject to prohibitions. Please consult with regulatory experts for your specific market requirements before proceeding.
Q: Do you offer custom particle size/micronization services?
A: Yes, particle size customization and micronization services are available upon request to meet specific formulation and dissolution requirements. Please provide your target particle size specifications (e.g., D90, D50) for quotation.
Why Choose Us?
Your Professional Manufacturing & Sourcing Partner
We are more than a supplier - we are a comprehensive supply chain partner dedicated to high-quality ingredients, custom formulations, and finished products across multiple industries.
Professional Expertise
With years of experience in plant extracts, food additives, cosmetic raw materials, and nutritional ingredients, our team brings deep technical knowledge and market insight to every partnership.
01
Diverse Product Range
We offer a broad range of products, including food additives, plant extracts, fruit & vegetable powders, cosmetic actives, and functional food ingredients.
02
One-Stop Shop
Raw Materials: High-purity ingredients for food, beverage, supplement, and cosmetic applications.
Finished Products: In-house manufacturing of capsules, soft gels, gummies, liquid drops, and blended powders.
03
OEM/ODM/OBM Services
Label Design & Packaging: Custom branding tailored to your target market.
Formulation & R&D: Expert support to develop custom blends, proprietary formulas, and innovative products.
Global Logistics: Reliable shipping, documentation, and customs clearance support.
04
Quality Assurance
Strict adherence to GMP standards and full regulatory transparency. We stay current with global requirements, including FDA GRAS, EFSA, and other regional regulations, to ensure your products meet the highest safety and compliance standards.
05
Contact Us
Contact our sales team to discuss your Cephalexin Powder requirements.
Please get in touch with us at ella.zhang@huilinbio-tech.com.
References
Disclaimer
This product is intended for use as an Active Pharmaceutical Ingredient (API) or pharmaceutical intermediate for manufacturing and formulation purposes only, not for direct human or animal consumption. This information is provided for B2B informational purposes only and does not constitute medical advice or therapeutic claims. Customers are solely responsible for complying with all applicable local, national, and international regulations, including obtaining necessary approvals from relevant health authorities before using this product in finished pharmaceutical or veterinary products. Specifications are subject to change without notice; please request current documentation before ordering.
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