PRODUCT SPECIFICATIONS | |
---|---|
Name of Product | Methylene Blue BP 1973 |
Pharmacopoeial Name | Methylene Blue BP 1973 |
Synonyms | Methylene Blue ; Basic Blue 9 ; C.I 52015 ; Methylene Blue Trihydrate |
CAS No | 122965-43-9 |
WHO-GMP | ✓ |
WC | ✓ |
DMF | ✓ |
US-DMF | ✓ |
SR. No | Criteria | Limit/Specification | Our Results |
---|---|---|---|
1 | Appearance | Dark Blue Crystalline Powder with a Copper- colored Sheen, or Green Crystals with a bronze-colored sheen. | Dark Green Crystals with a bronze-colored sheen. |
2 | Solubility | Must Pass Test | Passes Test |
3 | Identification | Must Pass A to D Tests Of B.P | Passes Tests Of B.P |
4 | Loss On Drying (At 75ËšC) | Limit: IN BETWEEN 8.0%-22.0% | 8.0 - 13.5 % |
5 | Sulphated Ash Test | NMT 0.25% | <0.1 % |
6 | Related Substances | Impurity A (Limit: Max.5.0%) Any other Impurity (Limit: Max.0.5%) Sum Of impurity Other then A (Limit: Max. 1.0%) Disregard Limit: Limit (0.1%) |
2.5 – 4.0 % a) Not Detected b) Not Detected c) 0 % |
7 | Heavy Metals | Must Comply as per BP | Complies with BP |
8 | Assay (With Reference To Subs. Dried At 105ËšC & As % Of (C 16H 18N 3ClS).H 2O |
MINIMUM 95.0% TO 101.0% MAXIMUM | 98.0 – 100.0 % |
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