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Molecular Structure
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Product Description and Specifications
| Tests |
Specifications |
| Description |
White crystals, commonly tabular or needle-like or white, crystalline powder. Is odorless or has a faint odor. Is stable in the dry air: in moist air it gradually hydrolyzes to salicylic and acetic acids. |
| Solubility |
Freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether; Slightly soluble in water. |
| Identification |
|
| A. by HPLC |
The RT of the major peak of the sample solution corresponds to that of the standard solution as obtained in the Assay |
| B. by IR spectroscopy |
The IR spectrum of the sample exhibits maxima only at the same wave numbers as that of a similar preparation of Aspirin WRS. |
| Assay by HPLC
(% w/w, on dried basis) |
Not less than 98.0 and Not more than 102.0 |
| Residue on ignition (% w/w) |
Not more than 0.05 |
| Chloride (%w/w) |
Not more than 0.014 |
| Sulfate (%w/w)
|
Not more than 0.04 |
| Organic Impurities by HPLC (% w/w) |
|
| Impurity A-4-Hydroxybenzoic acid |
Not more than 0.15 |
| Impurity B-4-Hydroxyisophthalic acid |
Not more than 0.15 |
| Impurity C-Salicylic acid |
Not more than 0.15 |
| Impurity D- Acetylsalicylsalicylic acid |
Not more than 0.15 |
| Impurity E-Salicylsalicylic acid |
Not more than 0.15 |
| Impurity F-Acetylsalicylic anhydride |
Not more than 0.15 |
| Any unspecified Impurity |
Not more than 0.10 |
| Total Impurities |
Not more than 0.25 |
| Loss on dryinf(%w/w) |
Not more than 0.5 |
| Additional Tests |
| Microbiological Testing |
For every Twentieth Lot / if required by customer |
Total aerobic Microbial count(TAMC) |
Not more than 1000 cfu/g |
| Total combined yeasts and moulds count (TYMC) |
Not more than 100 cfu/g |
| Bile-tolerant gram-negative baceteria |
Should be absent /g |
| Escherichia coli |
Should be absent /g |
| Salmonella species |
Should be absent /10g |
| Pseudomonas aeruginosa |
Should be absent /g |
| Staphylococceus aureus |
Should be absent /g |
| Candida albicans |
Should be absent /g |
| Un tapped density (Bulk Density) & Tapped Density (g/cc) |
As per Customer requirement |
| Particle size / Sieve analysis (%) |
As per Customer requirement |
| DETAILS OF STANDARD ASL GRADES
SPECIFICATIONS ( PARTICLE SIZE ) |
| S.NO. |
Grade |
Content |
Particle size Analysis |
Expiry Period |
| Mesh No. |
Limit( % ) |
| 1 |
ASL20 C (Crystals) |
Aspirin |
+ 20 |
NMT 4. 00 |
3 Years |
| + 80 |
NLT 70. 00 |
| 2 |
ASL40CP (Crystalline Powder) |
Aspirin |
+ 40 |
NMT 1. 00 |
3 Years |
| + 50 |
NMT 26. 00 |
| – 140 |
NMT 15.0 |
| 3 |
ASL60 CP (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 |
ASL60 GS
(Crystalline Powder) |
Aspirin |
+80 |
NMT 12. 00 |
3 Years |
| +200 |
NLT 50. 00 & NMT 75. 00 |
| +325 |
NLT 75.00 |
| 5 |
ASL80 CP (Crystalline Powder) |
Aspirin |
+60 |
NMT 0. 60 |
3 Years |
| +80 |
NMT 5.00 |
| 6 |
ASL 18 G (Granules) |
Aspirin |
-18 |
NLT 90.00 |
3 Years |
| +50 |
NLT 90.00 |
| 7 |
ASL 25 G
(Granules) |
Aspirin |
-25 |
NLT 95.00 |
3 Years |
| +60 |
NLT 95.00 |
|
| 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).
2. All retentions are cumulative. |
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) & 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
INSPECTIONS:
- US FDA 23rd – 27th March 2015
- EDQM 28th – 30th March 2011
- WHO GMP 13th – 14th June 2018
APPLICATIONS:
Blood thinning agent, Analgesic, Cardiology, Cough & Cold.
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
ADVANTAGES:
- Dedicated plant for Aspirin
- All raw materials for manufacturing Aspirin are in-house products, guaranteeing complete supply chain for our clients.
PACKING:
- For Indigenous: 25 kgs net laminated kraft paper bags inside LDPE Liner / 50 kgs. net HDPE drums inside 2 LDPE Liners.
- For 50/100 kgs net HDPE drums inside 2 LDPE liners and 1000 kgs net Super Sack inside LDPE liner.
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(% w/w, on dried
basis)
(% w/w, on dried basis) 
