A quick reference to the technical terms, certifications, pharmacopoeia standards, and industry abbreviations used across KingWish product pages. Bookmark this page for your API sourcing reference.
The official pharmacopoeia of the United States. Sets standards for identity, strength, quality, and purity of medicines. USP-grade APIs meet FDA-recognized specifications for the US market.
The official pharmacopoeia of the European Union, maintained by the EDQM. EP compliance is mandatory for APIs entering the European pharmaceutical market.
The national pharmacopoeia of the United Kingdom. Often aligned with EP monographs but maintains independent standards for certain substances.
The official pharmacopoeia of China, published by the Chinese Pharmacopoeia Commission. Required standard for APIs manufactured and sold within China.
The official standard for veterinary drugs in China. CVP-grade APIs meet Chinese regulatory requirements for animal drug products.
The official pharmacopoeia of India. IP-compliant APIs meet standards for the Indian pharmaceutical market, one of the world's largest.
Internationally recognized standard for food-grade ingredients. FCC compliance is essential for APIs used in food, beverage, and dietary supplement applications.
China's national standards system. GB-grade products meet mandatory quality and safety specifications for the Chinese domestic market.
A system ensuring products are consistently produced and controlled according to quality standards. GMP certification covers all aspects of production: premises, equipment, staff training, and hygiene. All KingWish manufacturing partners operate under GMP conditions.
The US federal agency responsible for protecting public health. FDA registration or approval is required for APIs sold into the US pharmaceutical market. KingWish products hold FDA VMF (Veterinary Master File) registrations.
Issued by the EDQM, a CEP certifies that an API complies with the relevant European Pharmacopoeia monograph. It replaces the need for separate DMF filings in each EU member state. A CEP significantly streamlines the European market access process.
A confidential document submitted to regulatory authorities (FDA, EMA) containing detailed information about an API's manufacturing process, quality control, and stability. DMF filing is a prerequisite for pharmaceutical customers to reference the API in their own regulatory submissions.
The veterinary equivalent of a DMF, filed with the FDA's Center for Veterinary Medicine (CVM). A VMF supports customer applications for veterinary drug approvals in the United States.
A document issued by the manufacturer's quality assurance department certifying that a specific batch meets all specifications. A CoA lists actual test results for parameters such as purity, residual solvents, heavy metals, and microbiological limits.
A document providing detailed information about a substance's hazards, safe handling procedures, storage requirements, and emergency measures. Required for international shipping and customs clearance of chemical products.
ISO certification (e.g., ISO 9001 for quality management) demonstrates that a manufacturer operates a documented, audited management system meeting international benchmarks.
A unique numerical identifier assigned to every chemical substance. The CAS number is the universal standard for identifying chemical compounds in international trade, regulatory filings, and scientific literature. Format: XXX-XX-X (e.g., 22189-32-8 for Spectinomycin HCl).
A notation indicating the number and type of atoms in a molecule. Essential for verifying chemical identity. Example: C14H24N2O7 · 2HCl · 5H2O for Spectinomycin HCl.
The mass of one molecule of a substance, measured in Daltons (Da) or grams per mole (g/mol). Used in pharmaceutical calculations for dosage formulation and quality control. Example: 495.35 g/mol for Spectinomycin HCl.
The percentage of the target compound in a sample, indicating chemical purity. Pharmaceutical-grade APIs typically require purity ≥98%, often ≥99%. Assay values are verified by HPLC, titration, or other validated analytical methods per pharmacopoeia monographs.
Organic volatile chemicals used or produced during API manufacturing that may remain in the final product. Limits are defined by ICH Q3C guidelines, which classify solvents into three risk classes with corresponding permitted daily exposure (PDE) limits.
Metallic elements (lead, mercury, cadmium, arsenic, etc.) that may be present as impurities. Pharmacopoeia monographs set strict limits for heavy metal content to ensure product safety. Testing follows USP <231> or equivalent EP/BP methods.
An international guideline from the International Council for Harmonisation (ICH) that classifies residual solvents by risk and sets acceptable concentration limits. Compliance with ICH Q3C is a standard requirement for pharmaceutical APIs.
An official document in a pharmacopoeia that specifies the quality standards for a specific substance. A monograph defines identity tests, assay methods, impurity limits, and storage conditions that an API must meet to claim compliance.
A manufacturer's internal quality specification that may exceed or complement pharmacopoeia standards. IN HOUSE standards are developed through the manufacturer's own R&D and quality control processes and can be tailored to specific customer requirements.
The ability of an API to maintain its specified quality attributes over time under defined storage conditions. Stability studies determine shelf life, recommended storage temperature, and packaging requirements. Results are documented in the DMF/CEP.
An internationally standardized numerical code for classifying traded products. Each API has a specific HS code used for customs declarations, tariff determination, and trade statistics. Example: 2941.90 for most antibiotic APIs.
An Incoterm where the seller delivers goods on board a vessel at the port of shipment. The buyer assumes all costs and risks from that point onward. Our quotations are typically FOB Qingdao unless otherwise stated.
An Incoterm where the seller covers the cost of goods, insurance, and freight to the destination port. CIF pricing provides the buyer with a delivered cost including marine insurance.
Standard packaging unit for pharmaceutical APIs. A fiber drum containing 25 kilograms of product, typically with an inner polyethylene liner to protect against moisture. Other packaging options (e.g., 1 KG / 5 KG / 10 KG) may be available upon request.
The smallest quantity a supplier will sell for a given product. For pharmaceutical APIs, MOQs vary by product. Contact us with your requirements for specific product MOQ information.
The time between order confirmation and shipment readiness. Typical lead times for pharmaceutical APIs range from 2-8 weeks depending on product availability, production scheduling, and required documentation preparation.
The biologically active component in a pharmaceutical drug product. APIs are the substances that produce the intended therapeutic effect. All KingWish pharmaceutical products are APIs supplied to drug manufacturers for formulation into finished dosage forms.
A substance that kills or inhibits the growth of bacteria. Includes aminoglycosides (Spectinomycin, Gentamycin), macrolides (Azithromycin, Clarithromycin, Tylosin), fluoroquinolones (Ciprofloxacin, Enrofloxacin), tetracyclines (Doxycycline), and β-lactams (Amoxicillin, Ampicillin).
A drug that expels or kills parasitic worms (helminths). Includes benzimidazoles (Albendazole, Fenbendazole) and macrocyclic lactones (Ivermectin). Used in both human and veterinary medicine.
A drug used to prevent or treat coccidiosis, a parasitic disease caused by Eimeria species, primarily in poultry. Includes Toltrazuril and Diclazuril.
A class of drugs that provide analgesic, antipyretic, and anti-inflammatory effects. Includes Paracetamol (Acetaminophen), Acetylsalicylic Acid (Aspirin), Piroxicam, and Diclofenac.
Essential organic compounds required in small quantities for normal metabolism. Includes water-soluble vitamins (B1, B5, C, Nicotinamide) and fat-soluble vitamins (Vitamin E). Supplied in food-grade (FCC) or pharmaceutical-grade (USP/EP) specifications.
Need clarification? Contact THOMAS QIAO for any questions about product specifications, regulatory requirements, or technical documentation. We respond within 24 business hours.