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Shaanxi Kaishi Biotechnology Co., Ltd
Product Description
Ciprofloxacin Lactate is a pharmaceutical active ingredient (API) salt form of ciprofloxacin, supplied as a high-purity powder for regulated pharmaceutical formulation and manufacturing applications. It is commonly used by pharmaceutical companies as a raw material for the development and production of ciprofloxacin lactate dosage forms under applicable quality and regulatory requirements.
Ciprofloxacin Lactate is the lactate salt of ciprofloxacin, a synthetic fluoroquinolone compound. Salt formation is commonly used in pharmaceutical development to improve handling characteristics and provide a suitable active pharmaceutical ingredient form for specific dosage applications.
As a pharmaceutical API, Ciprofloxacin Lactate requires strict control of identity, assay, impurities, residual solvents, and other quality attributes. Buyers typically evaluate API specifications, analytical methods, documentation, and regulatory support before procurement.
| Item | Specification |
|---|---|
| Product Name | Ciprofloxacin Lactate |
| Product Category | Pharmaceutical Active Ingredient (API) |
| Active Ingredient | Ciprofloxacin lactate salt |
| CAS Number | 97867-33-9 |
| Molecular Formula | C20H24FN3O3 · C3H6O3 |
| Molecular Weight | Approximately 439.46 g/mol |
| Appearance | White to slightly yellow crystalline powder |
| Assay | Pharmaceutical-grade assay according to applicable pharmacopeial or approved specifications |
| Identification | Conforms to reference standard identification requirements |
| Standard Test Method | HPLC and other validated pharmaceutical analytical methods |
| Related Substances | Controlled according to applicable API specifications |
| Water Content | Controlled according to product specification |
| Residual Solvents | Controlled according to applicable pharmaceutical requirements |
| Heavy Metals / Elemental Impurities | Controlled according to applicable standards |
| Storage | Store in a tightly sealed container in a cool, dry place protected from light and moisture |
| Shelf Life | Typically 24 months under recommended storage conditions |
| Packaging | Common pharmaceutical packaging options include sealed foil bags and fiber drums; customized packaging available |
For pharmaceutical API procurement, the key decision is not only active content but also quality consistency, analytical compliance, and documentation completeness. Buyers should evaluate Ciprofloxacin Lactate according to manufacturing requirements, dosage-form compatibility, and applicable market regulations.
| Evaluation Factor | Why It Matters | Buyer Consideration |
|---|---|---|
| Assay and Purity | Defines active ingredient consistency | Review assay method, specification limits, and batch COA data |
| Impurity Profile | Important for pharmaceutical quality control | Confirm related substances and impurity testing approach |
| Analytical Documentation | Supports regulatory and incoming inspection processes | Review COA, specification sheet, TDS, and analytical reports |
| Packaging and Stability Control | Helps maintain API quality during storage and transport | Evaluate moisture protection, sealing method, and storage conditions |
Pharmaceutical buyers require more than a product name and assay value. A reliable API supply process depends on traceable documentation, validated analytical testing, batch consistency, and controlled manufacturing practices. These factors help support quality evaluation and pharmaceutical development workflows.
Ciprofloxacin Lactate API requires comprehensive quality evaluation before pharmaceutical use. Standard API quality control may include:
Technical documentation such as COA, TDS, SDS, and analytical records can support procurement review and quality assessment procedures.
Ciprofloxacin Lactate is commonly supplied in pharmaceutical-grade sealed packaging designed to protect the material from moisture, contamination, and environmental exposure. Packaging formats can be adjusted according to project requirements.
The material should be stored in tightly sealed containers under cool, dry conditions and protected from direct light. Proper storage helps maintain API quality throughout the recommended shelf life.
Ciprofloxacin Lactate can support pharmaceutical development projects requiring API sourcing, documentation preparation, and ingredient supply coordination. Services may include specification support, technical documentation, packaging customization, and bulk API supply according to project requirements.
Pharmaceutical buyers should review the API specification sheet, batch COA, analytical reports, TDS, SDS, and relevant quality documentation. Important points include identity, assay, impurity profile, residual solvents, storage conditions, and batch consistency.
HPLC is a commonly used pharmaceutical analytical method for confirming active ingredient identity, assay, and purity-related parameters. Reliable analytical testing provides objective quality information for API evaluation and supplier comparison.
Ciprofloxacin Lactate should be stored in sealed packaging under cool, dry conditions and protected from excessive moisture, heat, and direct light. Storage conditions should follow the approved product specification and quality documentation.
API buyers should evaluate quality systems, analytical capability, documentation completeness, batch consistency, packaging standards, and supply reliability rather than comparing price alone.
Ciprofloxacin Lactate is a pharmaceutical API salt form requiring controlled quality management, accurate analytical verification, and reliable documentation. With appropriate specifications and quality controls, it supports pharmaceutical formulation and manufacturing projects. Contact us today to request samples, COA, technical documents, and a wholesale quotation for Ciprofloxacin Lactate API.
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