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Shaanxi Kaishi Biotechnology Co., Ltd
Product Description
Amoxicillin API Powder is a pharmaceutical-grade beta-lactam antibiotic active ingredient widely used in human and veterinary pharmaceutical manufacturing. Supplied as a controlled-quality raw material, amoxicillin is used for the development of oral dosage forms and other approved pharmaceutical formulations requiring consistent potency, purity, impurity control, and reliable analytical documentation.
Amoxicillin is a semi-synthetic aminopenicillin antibiotic belonging to the beta-lactam class. It is structurally related to ampicillin and is commonly supplied in pharmaceutical manufacturing as amoxicillin trihydrate or other approved forms depending on formulation requirements.
As a widely used pharmaceutical active ingredient, amoxicillin requires strict quality control throughout manufacturing and supply. Key quality factors include active ingredient identity, assay, related substances, water content, particle characteristics, and compliance with applicable pharmaceutical standards.
For API procurement, buyers should evaluate not only potency but also the specific amoxicillin form, analytical methodology, impurity profile, documentation package, and suitability for the intended dosage form.
| Item | Specification |
|---|---|
| Product Name | Amoxicillin API Powder |
| Product Category | Pharmaceutical Active Ingredient / Beta-Lactam Antibiotic |
| Active Compound | Amoxicillin |
| Common Form | Amoxicillin trihydrate |
| CAS Number | 26787-78-0 (Amoxicillin trihydrate) |
| Molecular Formula | C16H19N3O5S·3H2O (Amoxicillin trihydrate) |
| Molecular Weight | 419.45 g/mol (Amoxicillin trihydrate) |
| Appearance | White to almost white crystalline powder |
| Assay | Pharmaceutical-grade assay according to applicable amoxicillin specifications |
| Identification | Conforms to amoxicillin reference standard identification requirements |
| Standard Test Method | HPLC |
| Related Substances | Controlled according to pharmaceutical API specifications |
| Water Content | Controlled according to applicable pharmacopeial requirements |
| Particle Size | Fine powder; customizable according to formulation requirements |
| Microbial Quality | Controlled according to pharmaceutical standards |
| Shelf Life | Typically 24 months under recommended storage conditions |
| Storage | Store tightly sealed in a cool, dry place protected from moisture and direct light |
| Packaging | Pharmaceutical-grade foil bags and fiber drums; customized packaging available |
The key sourcing consideration for amoxicillin is selecting the appropriate chemical form and maintaining stability throughout storage and formulation. Amoxicillin is commonly supplied as amoxicillin trihydrate because hydration state, particle characteristics, and physical properties can influence processing performance.
| Evaluation Factor | Why It Matters | Buyer Consideration |
|---|---|---|
| Amoxicillin Form | Different forms may have different processing characteristics | Confirm whether the formulation requires trihydrate or another approved form |
| Assay and Purity | Determines active ingredient consistency | Review HPLC assay results and impurity limits |
| Moisture Control | Supports stability during storage | Evaluate water content data and packaging protection |
| Documentation Package | Supports pharmaceutical qualification | Review COA, TDS, SDS, and analytical records |
Amoxicillin is a beta-lactam compound where chemical stability and impurity control are important quality factors. Proper moisture management, suitable packaging, and validated analytical testing help manufacturers maintain consistent API quality during storage and production.
Amoxicillin API requires comprehensive pharmaceutical testing before release. Typical quality control procedures include:
COA, TDS, SDS, and technical documentation can be provided for pharmaceutical procurement review and supplier qualification procedures.
Amoxicillin API Powder is commonly supplied in pharmaceutical-grade sealed packaging designed to protect the material from moisture, contamination, and environmental exposure.
The product should be stored in tightly sealed containers under cool and dry conditions. Protection from humidity, heat, and direct light helps maintain API quality throughout storage.
Amoxicillin can support pharmaceutical projects requiring API sourcing, specification review, technical documentation, packaging customization, and bulk ingredient supply coordination.
Amoxicillin trihydrate is one of the commonly supplied pharmaceutical forms of amoxicillin. Buyers should confirm the required form according to the intended dosage form and manufacturing process.
HPLC helps confirm amoxicillin identity, assay, and related substance levels. Reliable analytical testing supports consistent pharmaceutical raw material quality and supplier evaluation.
Buyers should review the specification sheet, batch COA, analytical reports, TDS, SDS, and quality documentation. Important points include assay, impurities, water content, storage requirements, and batch consistency.
Amoxicillin should be stored in sealed packaging under cool and dry conditions, protected from moisture, heat, and direct light. Storage conditions should follow product specifications and technical documentation.
Amoxicillin API Powder is a widely used beta-lactam pharmaceutical ingredient requiring controlled stability management, analytical verification, and reliable documentation. With appropriate quality specifications and professional supply support, amoxicillin provides a dependable raw material option for pharmaceutical formulation development. Contact us today to request samples, a COA, technical documents, and a wholesale quotation for Amoxicillin API Powder.
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Privacy statement: Your privacy is very important to Us. Our company promises not to disclose your personal information to any external company with out your explicit permission.