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METHYLENE BLUE BP 1973

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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 ✓

SPECIFICATIONS

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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