Central Nervous System
C15H12N2O2
Molecular weight: 252,28
Code :
10272
Description :
White to cream crystalline powder.
Melting point:
Min. 214,0°C
Sulphated ashes :
Max. 0,1 %
Loss on drying :
Max. 0,5 %
Assay (HPLC) :
98,5 – 101,5 %
Impurities (HPLC) :
Oxcaruree : Max. 0,1 %
Any other impurity : Max. 0,1 %
Sum of impurities : Max. 0,5 %
Packaging :
C9H8N2O2
Molecular weight: 176,17
Code :
10089
Description :
White to slightly cream crystalline powder.
Melting point :
240,0 – 250,0 °C
Sulphated ashes :
Max. 0,10 %
Assay :
98,0 - 101,0 %
Impurities (HPLC) :
Mandelic acid : Max. 0,2 %
Ethyl mandelate : Max. 0,2 %
Any unknown impurity : Max. 0,1 %
Sum of impurities : Max. 1,0 %
Packaging :
C20H22ClNO2
Molecular weight: 343,85
Code :
11950
Description :
White crystalline powder.
Sulphated ashes :
Max. 0,1 %
Assay :
99,0 - 101,0 %
Impurities (HPLC) :
Each impurity : Max. 0,1 %
Sum of impurities : Max. 0,5 %
References :
DAC
Packaging :
C14H20ClNO2
Molecular weight: 269,77
Code :
10230
Description :
White to off-white powder.
Sulphated ashes :
Max. 0,1 %
Assay :
98,0 – 100,5 %
Impurities (TLC) :
Methylphenidate erythro (R*,S*) isomer : Max. 1 %
Alpha-phenyl-2-piperidineacetic acid HCl : Max. 0,6 %
References :
USP
Packaging :
C13H20ClNO
Molecular weight: 241,76
Code :
11551
Description :
White crystalline powder.
Solubility :
Clear solution
Assay :
98,0 – 101,0 %
Impurities (HPLC) :
Sum of impurities : Max. 0,5 %
Tartaric Acid :
0,9 – 1,1 %
C8H17NO7
Molecular weight: 239,23
Code :
11480
Description :
White crystalline hygroscopic powder.
Melting point :
110,0 – 113,0 °C
Sulphated ashes :
Max. 0,10 %
Assay :
98,0 - 101,0 %
Impurities (TLC) :
Sum of impurities : Max. 1,0 %
Packaging :
C12H24N2O4
Molecular weight: 260,33
Code :
11020
Description :
White crystalline powder.
Melting point :
92,0 – 94,0 °C
Sulphated ashes :
Max. 0,10 %
Assay :
98,0 - 102,0 %
Impurities (TLC) :
Meprobamate : Max. 0,5 %
Any unknown impurity : Max. 0,1 %
Sum of impurities : Max. 1,0 %
References :
USP
Packaging :
C15H12N2O
Molecular weight: 236,27
Code :
10950
Description :
White to almost white crystalline powder.
Sulphated ashes :
Max. 0,10 %
Assay :
98,0 - 102,0 %
Impurities (HPLC) :
10,11-Dihydrocarbamazepine : Max. 0,1 %
Iminodibenzyle : Max. 0,1 %
Any other impurity : Max. 0,1 %
Sum of impurities : Max. 0,5 %
X-ray diffraction :
Complies with USP reference