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COA & MSDS for Pharmaceutical APIs — Request Sample Documentation | Aarise Pharmaceuticals
Aarise Pharmaceuticals provides batch-specific Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) for all APIs and finished formulations we supply. Full documentation is available before you place your order — no surprises.
Need COA and MSDS for a specific API?
+91 9899783330
Request Sample Documentation → — provided within 24 hours.
APIs We Supply — With Full COA and MSDS
Request COA, MSDS, purity specs, and stability data for any of the following:
Dispersible Tablet APIs
| API | CAS Number | Purity | Pharmacopeia |
|---|---|---|---|
| Paracetamol (Acetaminophen) | 103-90-2 | ≥99.0% | USP / BP / IP |
| Amoxicillin Trihydrate | 61336-70-7 | ≥95.0% | USP / BP |
| Ibuprofen | 15687-27-1 | ≥99.0% | USP / BP / IP |
| Diclofenac Sodium | 15307-79-6 | ≥99.0% | USP / BP |
| Metronidazole | 443-48-1 | ≥99.0% | USP / BP / IP |
Hormone APIs
| API | CAS Number | Purity | Pharmacopeia |
|---|---|---|---|
| Testosterone Enanthate | 315-37-7 | ≥98.0% | USP / BP |
| Testosterone Cypionate | 58-20-8 | ≥98.0% | USP |
| Progesterone | 57-83-0 | ≥99.0% | USP / BP / IP |
| Estradiol | 50-28-2 | ≥98.0% | USP / BP |
| Dexamethasone | 50-02-2 | ≥99.0% | USP / BP / IP |
| Prednisone | 53-03-2 | ≥99.0% | USP / BP |
Anti-infective APIs
| API | CAS Number | Purity | Pharmacopeia |
|---|---|---|---|
| Ciprofloxacin HCl | 86393-32-0 | ≥99.0% | USP / BP |
| Azithromycin | 83905-01-5 | ≥97.0% | USP / BP |
| Clarithromycin | 81103-11-9 | ≥98.0% | USP / BP |
Cardiovascular & Metabolic APIs
| API | CAS Number | Purity | Pharmacopeia |
|---|---|---|---|
| Metformin HCl | 1115-70-4 | ≥99.0% | USP / BP / IP |
| Atorvastatin Calcium | 134523-03-8 | ≥98.0% | USP / BP |
| Losartan Potassium | 124750-99-8 | ≥99.0% | USP / BP |
| Omeprazole | 73590-58-6 | ≥98.5% | USP / BP / IP |
| Montelukast Sodium | 151767-02-1 | ≥98.0% | USP / BP |
Don’t see your molecule? Contact us → — we supply 100+ APIs.
What Our COA Contains
Every Certificate of Analysis from Aarise is batch-specific — not a generic template. It includes:
- Product name, CAS number, molecular formula
- Batch/Lot number and manufacturing date
- Expiry date and storage conditions
- Assay (purity %) — confirmed by HPLC
- Related substances / impurity profile
- Residual solvents (ICH Q3C compliant)
- Heavy metals (where applicable)
- Microbial limits (where applicable)
- Pharmacopeial compliance (USP / BP / IP / EP)
- QC analyst signature and QA approval
- NABL-accredited lab stamp
We do not issue generic COAs. Every batch gets its own testing and documentation.
What Our MSDS Contains
Our Material Safety Data Sheet (MSDS / SDS) follows GHS / OSHA format and includes:
- Section 1: Product identification and supplier details
- Section 2: Hazard identification (GHS classification)
- Section 3: Composition / ingredients (CAS number, concentration)
- Section 4: First aid measures
- Section 5: Fire fighting measures
- Section 6: Accidental release measures
- Section 7: Handling and storage conditions
- Section 8: Exposure controls / PPE
- Section 9: Physical and chemical properties
- Section 10–16: Stability, toxicology, transport, regulatory info
Required for: customs clearance, workplace safety compliance, regulatory submissions, and pharmaceutical manufacturing audits.
Additional Documentation We Provide
Beyond COA and MSDS, we also supply:
| Document | Purpose |
|---|---|
| Stability Data | Shelf-life validation per ICH Q1A |
| Drug Master File (DMF) | US FDA ANDA/NDA submissions |
| Certificate of Pharmaceutical Product (COPP) | WHO format, for regulated markets |
| WHO GMP Certificate | Facility certification |
| Certificate of Origin | Customs and import documentation |
| Regulatory Dossier Support | Market-specific submission support |
Why COA and MSDS Matter for International Buyers
For customs clearance: Most countries require MSDS for pharmaceutical imports. Without it, shipments can be held or rejected at the border.
For regulatory submissions: If you are submitting an ANDA (USA), MA (EU), or equivalent in your market, your API supplier’s COA and DMF status are mandatory parts of the dossier.
For your own QC: A batch-specific COA lets you verify our results in your own lab before using the API in production. This is standard practice for any regulated pharmaceutical manufacturer.
Red flag to watch for: Any supplier who cannot provide a batch-specific COA within 24 hours of being asked — walk away.
How to Request Documentation from Aarise
+91 9899783330 | +91 9289410333
Frequently Asked Questions
Can I get COA and MSDS before placing an order?
Yes, always. We provide documentation before any order commitment. This is standard at Aarise.
Are your COAs issued by an NABL-accredited lab?
Yes. Our in-house QC laboratory is NABL-accredited. All analytical results are generated and verified internally.
Do you provide DMF (Drug Master File) support?
Yes. We provide DMF support for API buyers making submissions to US FDA. Contact us for details.
Can you provide COA in a specific format required by my regulatory authority?
Yes. We can adapt documentation format to meet ANVISA, COFEPRIS, INVIMA, MFDS, and other regulatory requirements. Tell us your market and we will prepare accordingly.
How recent are your COA batches?
We manufacture on an ongoing basis. Fresh batch COA is available for all major molecules. Specify your required quantity and we will confirm batch availability.
Request COA, MSDS, or Sample Documentation
+91 9899783330 | +91 9289410333
Aarise Pharmaceuticals | WHO GMP Certified API Supplier | Haridwar & Hyderabad, India | aarisepharma.com