Titriplex® III (ethylenedinitrilotetraacetic acid disodium salt dihydrate), EMPROVE® ESSENTIAL BP, Ph. Eur., JP, USP suitable for use as excipient, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS
Warning


M-Clarity™ quality level = MQ500

1.08421.1000 1.08421.9025 1.08421.2500
1.08421.1000EA 345 EUR
1.08421.1000 1.08421.9025 1.08421.2500
Titriplex® III (ethylenedinitrilotetraacetic acid disodium salt dihydrate), EMPROVE® ESSENTIAL BP, Ph. Eur., JP, USP suitable for use as excipient, SAFC®
EDTA disodium salt dihydrate

Elemental impurity specifications have been set considering /CH 030 (Guideline for Elementallmpurities).
Glass 1-3 elements are not likely to be present above the /CH 030 option 1 limit, unless specified and indicated (*).


Certifications: Corresponds to Ph Eur, BP, JP, USP.

Formula: C₁₀H₁₄N₂Na₂O₈·2H₂O
MW: 372.24 g/mol
Melting Pt: 255
Storage Temperature: Ambient
MDL Number: MFCD00150037
CAS Number: 6381-92-6
EINECS: 205-358-3
Merck Index: 13,03543
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Specification Test Results

Assay (calc. on dried substance) 99.0- 101 .0 %
Assay (calc. as dihydrate) 99.0- 101.0 %
Identification (IR) Complies
ldentity complexation (edetate) Complies
ldentity of sodium Complies
Appearance White to almost white, crystalline powder
Appearance of solution (5%, water) Clear and colorless
pH (1%, water) 4.3-4.7
pH (5%, water) 4.0- 5.5
Cyanide (CN) Not more than 1 ppm
Heavy metals (as Pb) Not more than 10 ppm
Arsenic (As) Not more than 1 ppm
Iron (Fe) Not more than 5 ppm
Calcium (Ca) Complies
Nitrilotriacetic acid Not more than 0.1 %
Methanol (GC) Not more than 3000 ppm
Loss on drying 8. 7 - 11.4 %
Sulphated ash 37.0- 39.0 %
Other residual solvents (ICH Q3C) Excluded by production process


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