Specifications

Pack type:
HDPE pail, Flowmor™
Pk:
12 kg
Seq:
4187

Specifications

Specification Test Results

EP/BP - Assay (C₆H₉N₃O₂·HCl) (dried basis):
98.5 - 101.0 %
EP/BP - Identification A:
Passes Test
EP/BP - Identification B:
Passes Test
EP/BP - Identification C:
Passes Test
EP/BP - Identification F:
Passes Test
EP/BP - Appearance of Solution:
Passes Test
EP/BP - pH:
3.0 - 5.0
EP/BP - Specific Rotation [Å]²º^D (+):
9.2 - 10.6 Degree
EP/BP-Ninhydrin-Positive Substances-Each:
≤0.2 %
EP/BP-Ninhydrin-Positive Substances-Total Impurities:
≤0.5 %
EP/BP - Sulfate (SO₄):
≤300 ppm
EP/BP - Ammonium (NH₄):
≤0.02 %
EP/BP - Iron (Fe):
≤10 ppm
EP/BP - Loss on Drying at 150°C:
7.0 - 10.0 %
EP/BP - Ash (sulfated):
≤0.1 %
JP - Identification:
Passes Test
JP - Optical Rotation (+):
9.2 - 10.6
JP - pH:
3.5 - 4.5
JP - Clarity and Color of Solution:
Passes Test
JP - Sulfate (SO₄):
≤0.028 %
JP - Ammonium (NH₄):
≤0.02 %
JP - Heavy Metals (as Pb):
≤10 ppm
JP - Iron (Fe):
≤10 ppm
JP - Related Substances:
Passes Test
JP - Water:
7.2 - 10.0 %
JP - Residue on Ignition:
≤0.10 %
JP - Assay (anhydrous basis):
99.0 - 101.0 %
Endotoxin Concentration, IU/mg ,For Information Only:
≤ 0.10 %
No Class 1,2,3 or other solvents are used or produced in the:
99.0 - 101.0 %
manufacturing or purification of the product.:
≤ 0.02 %
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product.:
≤ 10 ppm
Elemental Impurities (USP 232, EP 5.20) - Information on elemental:
≤ 10 ppm
impurities for this product is available on the associated Product:
Passes Test
Regulatory Data Sheet and elemental impurity profile report.:
7.2 - 10.0 %

Specification Test Results

About this item

:209.63 g/mol

Merck Index:13,04741

Melting Pt:259 °C

Density:1.485 g/cm³ (20 °C)

Storage Temperature:Ambient

EINECS:211-438-9

CAS Number:5934-29-2

Formula:C₆H₉N₃O₂·HCl·H₂O

MDL Number:MFCD00151027