Description
Aspirin IP
| Molecular Formula | C9H8O4 |
| CAS Registry No | [50 – 78 – 2] |
| Molecular weight | 180.2 |
| Reference | I.P-Addendum 2015 |
| Chemical Name | Acetylsalicylic acid |
| Other names | 2 – Acetoxybenzoic acid. |
| 0 – Acetoxybenzoic acid | |
| HSN : | 2918 2200 |
Molecular Structure
Product Description and Specifications
| S.No. | Tests | Specifications |
| 1 | Description | Colourless crystals or white, crystalline powder: odourless or almost odourless. |
| 2 | Solubility | Freely soluble in ethanol (95%): soluble in chloroform and in ether: slightly soluble in water. |
| 3 | Identification | Test A may be omitted if tests B and C are carried out. Tests B and C may be omitted if Test A is carried out. A. IR spectrum of the sample is concordant with that of Aspirin WRS. B. A deep violet colour with ferric chloride solution. C. On heating with sulphuric acid, odour of ethyl acetate perceptible. |
| 4 | Appearance of solution | A 1% w/v solution in ethanol (95%) is clear and not more intensely coloured than reference solution BS8. |
| 5 | Clarity of solution in alkali | A 5% w/v solution in warm 5% w/v solution of sodium carbonate is clear. |
| 6 | Related Substances (%w/w by HPLC) | |
| Impurity A | 4-Hydroxybenzoic acid NMT 0.15 | |
| Impurity B | 4-Hydroxyisophthalic acid NMT 0.15 | |
| Impurity C | Salicylic acid NMT 0.15 | |
| Impurity D | Acetylsalicylsalicylic acid NMT 0.15 | |
| Impurity E | Salicylsalicylic acid NMT 0.15 | |
| Impurity F | AcetylSalicylic anhydride NMT 0.15 | |
| Any other secondary Impurity | NMT 0.05 | |
| Sum of Impurities | NMT 0.25 | |
| 7 | Arsenic | Sample stain shall not be more intense than Standard stain. (2 ppm) |
| 8 | Heavy metals | Not more than 10 ppm |
| 9 | Chlorides | Not more than 430 ppm |
| 10 | Sulphates | Not more than 650 ppm |
| 11 | Readily Carbonisable substances | A 10% solution in H2SO4(94.5 – 95.5%w/w); any colour produced is not more than that of reference solution BYS4. |
| 12 | Sulphated Ash | Not more than 0.1% |
| 13 | Loss on drying | Not more than 0.5% |
| 14 | Assay (By HPLC) | NLT 99.50 % & NMT 100.50 % |
Details of Standard ASL Grades & Particle Size(PSD) Specifications
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* We are also producing as per customer specifications regarding Particle Size Distribution. Note:1. Sieve analysis is carried out on sieve shaker RETSCH AS-200 (Electromagnetic Sieve Shaker). |
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CERTIFICATIONS AND ACCREDITATIONS
- US FDA inspected and approved
- EDQM inspected and approved
- WHO GMP
- Written Confirmation issued by CDSCO, New Delhi
- US DMF No. 16345 (Aspirin USP) & 17816 (Aspirin Starch Granules)
- CEP/COS No. R1-CEP 2000-042-Rev03
- ISO 9001:2015; ISO 14001:2015; and OHAS 18001:2007 Management System Standards
- GDUFA registered, and GDUFA Facility & DMF fees paid
APPLICATIONS
- Blood-thinning agent, Analgesic,
- Cardiology, Cough & Cold.
INSPECTIONS
US FDA 23rd – 27th March 2015
EDQM 28th – 30th March 2011
WHO GMP 13th – 14th June 2018
FIELD OF ACTIVITY
Consumer Health
PACKING
- 25 kgs net laminated kraft paper bags inside LDPE Liner
- 50 kgs net HDPE drums inside 2 LDPE Liners
- 50 kgs net FIBRE drums inside 2 LDPE Liners
- 100 kgs net HDPE drums inside 2 LDPE liners and
- 1000 kgs net Super Sacks inside LDPE liner.
ADVANTAGES
- Dedicated plant for Aspirin
- All raw materials for manufacturing Aspirin are in-house products, guaranteeing complete supply chain for our clients.
