Description
Acetylsalicylic acid Ph.Eur.
| Molecular Formula | C9H8O4 |
| CAS Registry No. | [50 – 78 – 2] |
| Molecular weight | 180.2 |
| Reference | EP |
| 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 | Appearance | White or almost white, crystalline powder or colourless crystals. |
| 2 | Solubility | Slightly soluble in water, freely soluble in ethanol (96 percent). |
| 3 | Melting point | About 143ºC (Instantaneous Method) |
| 4 | Identification | First identification : A, B. Second identification : B, C, D. |
| A. IR absorption Spectrophotometry | The Transmission minima (or absorption maxima) in the spectrum obtained with the sample corresponds in position and relative size to those in the spectrum obtained with Acetylsalicylic acid WRS. | |
| B. Melting point of precipitate | 156º to 161ºC | |
| C. Colour test. | The colour becomes blue. | |
| D. Reaction of Salicylates | The solution gives reaction (a) of Salicylates. | |
| 5 | Appearance of solution | The solution is clear and colourless. |
| 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 | |
| Unspecified Impurity | NMT 0.05 | |
| Total Impurities | NMT 0.25 | |
| 7 | Loss on drying (%, w/w) (Determined on 1g by drying in vacuo) | Maximum 0.5 |
| 8 | Sulphated Ash (%, w/w, determined on 1g) | Maximum 0.1 |
| 9 | Assay (%, w/w, dried substance) | 99.5 to 101.0 |
Details of Standard ASL Grades & Particle Size(PSD) Specifications
| S.No. | Grade | Content | Particle Size Analysis | Expiry Period | ||
| Mesh No. | Limit (%) | |||||
| 1 | ASL 20C (Crystals) | Aspirin | + 20 | NMT 4. 00 | 3 Years | |
| + 80 | NLT 70. 00 | |||||
| 2 | ASL 40CP (Crystalline Powder) | Aspirin | + 40 | NMT 1. 00 | 3 Years | |
| + 50 | NMT 26. 00 | |||||
| – 140 | NMT 15.0 | |||||
| 3 | ASL 60CP (Crystalline Powder) | Aspirin | +60 | NMT 5. 00 | 3 Years | |
| +85 | NLT 5. 00 & NMT 10. 00 | |||||
| +100 | NLT 18. 00 & NMT 30. 00 | |||||
| +170 | NLT 46. 00 & NMT 60. 00 | |||||
| 4 | ASL 60GS (Crystalline Powder) | Aspirin | +80 | NMT 12. 00 | 3 Years | |
| +200 | NLT 50. 00 & NMT 75. 00 | |||||
| +325 | NLT 75.00 | |||||
| 5 | ASL 80CP (Crystalline Powder) | Aspirin | +60 | NMT 0. 60 | 3 Years | |
| +80 | NMT 5.00 | |||||
| 6 | ASL 18G (Granules) | Aspirin | -18 | NLT 90.00 | 3 Years | |
| +50 | NLT 90.00 | |||||
| 7 | ASL 25G (Granules) | Aspirin | +25 | NMT 15.00 | 3 Years | |
| +60 | NLT 70.00 | |||||
| +120 | NLT 90.00 | |||||
| 8 | ASL 230GS (Crystalline Powder) | Aspirin | -45 | NLT 95.00 | 3 Years | |
| +60 | NMT 3.00 | |||||
| +230 | NMT 60.00 | |||||
* We are also producing as per customer specifications regarding Particle Size Distribution. 2. All retentions are cumulative. | ||||||
CERTIFICATIONS AND ACCREDITATION
- 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. CEP 2000-042-Rev05
- ISO 9001:2015; ISO 14001:2015; and ISO 45001:2018 Management System Standards
- GDUFA registered, and GDUFA Facility & DMF fees paid
CAUTIONS
- Toxic, Harmful if swallowed.
- If absorbed through skin, causes skin irritation.
- If inhaled, causes respiratory irritation.
- Causes serious eye irritation.
FIELD OF ACTIVITY
Consumer Health
INSPECTIONS
US FDA 09th – 13th September 2024
EDQM 28th – 30th March 2011
WHO GMP 10th – 11th March 2025
ADVANTAGES
- Dedicated plant for Aspirin.
- All raw materials for manufacturing Aspirin are in-house products, guaranteeing complete supply chain for our clients.
APPLICATIONS
Blood thinning agent, Analgesic, Cardiology, Cough & Cold.
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.
The Andhra Sugars Limited was established on the 11th of August, 1947. We have used locally available renewable resources to produce value-added products, generating employment for the rural population and helping in boosting the rural economy.
Product Category
Location Map
Contact Us
- The Andhra Sugars Limited Venkatarayapuram Tanuku - 534215 . West Godavari District ( A.P)
-
+91 8819 - 224911
( 7 Lines )
FAX: +91 8819-224168 - info.tnk@theandhrasugars.com
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