Certifications & Quality
Certified facilities. Proof on paper.
We're asset-light: we own the formulation, sourcing, quality control and program management, and manufacture across an audited partner network. Those facilities operate to the standards below — and every batch leaves with its Certificate of Analysis.
Standards
The standards our partner facilities hold.
WHO-GMP / cGMP
Good Manufacturing Practice.
FSSAI Licensed
Food Safety & Standards Authority of India.
ISO 22000 / FSSC 22000
Food-safety management systems.
Halal Certified
Halal-compliant production available.
Kosher Certified
Kosher-compliant production available.
Certifications are held by our manufacturing partners and apply to the facilities and lines producing your goods. Specific certificates and scope are shared, per program, during onboarding and on request.
Every batch
Identity. Potency. Proof.
Three questions every honest batch has to answer before it ships — documented on a Certificate of Analysis you can hand to a regulator, a doctor or a distributor.
Identity
What is it, exactly?
The compound is confirmed against a certified reference — by spectrum and chromatographic fingerprint — before anything else happens.
Potency
How much is really there?
The active is quantified by HPLC and standardised to a declared strength, so the dose on the label is the dose in the capsule.
Proof
Can you show it?
Identity, potency and purity arrive in writing — a Certificate of Analysis tied to a traceable batch. Every time.
Certificate of Analysis
Insignis Bioscience · QC release
- Product
- Berberine HCl 97% — Capsules
- Active
- HIMABERB® berberine
- Batch no.
- SPECIMEN
- Format
- 500 mg · 60 caps
- Mfg. standard
- WHO-GMP
- Status
- Released
| Test | Method | Specification | Result | Status |
|---|---|---|---|---|
| Identity — Berberine HCl | HPLC fingerprint | Conforms to reference | Conforms | Pass |
| Assay (potency) | HPLC | ≥ 485 mg berberine HCl per capsule (≥97% of label claim) | 496 mg / capsule (99.2% LC) | Pass |
| Loss on drying | USP <731> | ≤ 7.0% | 4.1% | Pass |
| Heavy metals — Lead | ICP-MS · USP <232> | ≤ 0.5 ppm | < 0.1 ppm | Pass |
| Total plate count | USP <2021> | ≤ 10,000 CFU/g | 120 CFU/g | Pass |
| Yeast & mould | USP <2021> | ≤ 100 CFU/g | < 10 CFU/g | Pass |
| E. coli / Salmonella | USP <2022> | Absent | Absent | Pass |
Representative specimen. Every production batch is tested and ships with its own Certificate of Analysis tied to a traceable lot.
— specimen —
Reviewed · Quality Assurance
Ask us for the paperwork.
Certificates, specs and a sample COA — we're glad to share them. Tell us the product and market, and we'll show you exactly what ships with it.