In regulated pharmaceutical manufacturing, ingredient quality and documentation are everything. One such critical ingredient is Calamine, widely used in topical products for its soothing and skin-protective properties. For businesses seeking a Calamine IP/BP/USP Grade Supplier, selecting a compliant, quality-driven partner is key to ensuring safety, efficacy, and regulatory approval.
At Chemignition Laboratory, we specialize in the GMP-certified production and export of pharma-grade calamine powder, compliant with the world’s top pharmacopeial standards — Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP).
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What is IP/BP/USP Grade Calamine?
IP/BP/USP Grade Calamine refers to calamine powder manufactured under stringent quality control processes and tested to meet the monograph standards of major pharmacopeias:
- IP (Indian Pharmacopoeia)
- BP (British Pharmacopoeia)
- USP (United States Pharmacopoeia)
These standards define the assay limits, purity levels, heavy metals, microbial content, and physical characteristics needed for pharmaceutical use. Using IP/BP/USP-compliant ingredients ensures that finished products meet global safety and efficacy guidelines.
Pharmaceutical Applications of Calamine
Calamine is a non-toxic, zinc-based powder primarily made of zinc oxide and a small quantity of iron oxide, giving it its characteristic pale pink color. In pharma, it’s used in:
| Formulation | Purpose |
|---|---|
| Calamine Lotion | Treats itching, rashes, insect bites, chickenpox |
| Ointments & Creams | Used in burn and sunburn treatments |
| Anti-Itch Preparations | Soothes eczema, dermatitis, and allergic skin reactions |
| Medicated Powders | Keeps skin dry and irritation-free in humid conditions |
| Pediatric Use | Ideal for baby diaper rash creams and talcum formulations |
Typical Specifications of IP/BP/USP Grade Calamine
| Property | Specification |
|---|---|
| Appearance | Pink fine powder |
| Zinc Oxide (ZnO) Content | 98.5% – 100.5% |
| Iron Oxide (Fe₂O₃) Content | 0.4% – 1.0% |
| pH (5% suspension) | 6.5 – 8.0 |
| Moisture Content | Not more than 1.0% |
| Heavy Metals | Complies with pharmacopeial limits |
| Microbial Limits | Tested per GMP protocols |
| Solubility | Insoluble in water, soluble in acids |
Why Choose Chemignition as Your Calamine IP/BP/USP Supplier?
Chemignition Laboratory is an industry-trusted manufacturer and global supplier of pharma-grade calamine powder, serving clients in more than 50 countries.
Here’s what sets us apart:
| Feature | Benefit |
|---|---|
| GMP & ISO 9001:2015 Certified | Global regulatory compliance |
| In-House QA/QC Laboratory | Batch-level testing and traceability |
| Custom Packaging Solutions | Drums, bags, vacuum-sealed pouches |
| Regulatory Documentation | COA, MSDS, TDS, Origin Certificate, GMP/ISO Certifications |
| Global Logistics Support | Air/Sea shipping with real-time tracking and customs-ready formats |
| Responsive Support | Dedicated export and technical team |
Documents We Provide
For each bulk shipment, Chemignition supplies:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- GMP Certificate
- ISO 9001:2015 Certificate
- Certificate of Origin
- Packing List & Commercial Invoice
All documentation aligns with audit and registration requirements for regulated markets.
Global Market Coverage
Chemignition Laboratory currently supplies Calamine IP/BP/USP grade to pharmaceutical companies, distributors, and formulation houses in:
- United States
- United Kingdom
- Germany
- UAE
- Bangladesh
- Nigeria
- Vietnam
- South Africa
- Sri Lanka
- Latin America
Who Should Source from Us?
Our calamine is ideal for:
- Pharmaceutical Manufacturers
- Contract Formulators
- Exporters of Topical Medications
- R&D Laboratories
- Baby Care Product Brands
Request Bulk Quote or Sample Today
Ready to scale your formulation or product line with trusted calamine?
Get in touch with us for samples, bulk pricing, and packaging options.
Website: www.chemignition.com
FAQs
What does IP/BP/USP grade calamine mean?
It means the calamine meets the specifications outlined in the Indian, British, or U.S. Pharmacopoeia, ensuring it is safe and effective for pharmaceutical use.
Can I use this calamine for cosmetic or veterinary use?
Yes, many cosmetic and veterinary products use calamine that complies with pharmacopeial standards for added safety and performance.
Is your calamine tested for microbial contamination?
Absolutely. All pharma-grade batches are tested for microbial limits under GMP guidelines.
What’s the shelf life of your IP/BP/USP grade calamine?
Our calamine typically has a shelf life of 3 years when stored in its original packaging under cool, dry conditions.
Do you support white-label or OEM requests?
Yes. We provide OEM/private-label packaging solutions for bulk buyers and international distributors.
