Calamine IP/BP/USP Grade Supplier – Quality Ingredients for Regulated Pharma Use

Kapil Radadiya
Written by Kapil Radadiya
Calamine IP/BP/USP Grade Supplier – Quality Ingredients for Regulated Pharma Use

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).

Explore a leading manufacturer of APIs.

With over 10 years of expertise, we ensure GMP compliance and provide reliable, high-quality solutions.

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:

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:

FormulationPurpose
Calamine LotionTreats itching, rashes, insect bites, chickenpox
Ointments & CreamsUsed in burn and sunburn treatments
Anti-Itch PreparationsSoothes eczema, dermatitis, and allergic skin reactions
Medicated PowdersKeeps skin dry and irritation-free in humid conditions
Pediatric UseIdeal for baby diaper rash creams and talcum formulations

Typical Specifications of IP/BP/USP Grade Calamine

PropertySpecification
AppearancePink fine powder
Zinc Oxide (ZnO) Content98.5% – 100.5%
Iron Oxide (Fe₂O₃) Content0.4% – 1.0%
pH (5% suspension)6.5 – 8.0
Moisture ContentNot more than 1.0%
Heavy MetalsComplies with pharmacopeial limits
Microbial LimitsTested per GMP protocols
SolubilityInsoluble 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:

FeatureBenefit
GMP & ISO 9001:2015 CertifiedGlobal regulatory compliance
In-House QA/QC LaboratoryBatch-level testing and traceability
Custom Packaging SolutionsDrums, bags, vacuum-sealed pouches
Regulatory DocumentationCOA, MSDS, TDS, Origin Certificate, GMP/ISO Certifications
Global Logistics SupportAir/Sea shipping with real-time tracking and customs-ready formats
Responsive SupportDedicated 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.