PRODUCT
INFORMATION
| 1 |
Name of the product: | Olanzapine
| |
| |
2 | Specifications: | As
per in house specifications | |
3 | Capacity
of the product : | 100
KGS per month | |
4 |
Batch size/Batch cycle : | Batch
Size : 10 / 50 Kgs Batch Cycle : 10 days | |
5 | Lead
time for supply of product : | 1
to 2 Weeks upon receipt of order confirmation. | TECHNICAL
DATA OF OLANZAPINE 2-methyl-4-(4-methyl-1-piperazinyl)-10H[2,3-b][1,5]benzodiazepine 
C. A. S. No. 132539-06-1 C17
H20 N4 S , mol. wt. 312.44 C 65.35%, H 6.45% N 17.93%, S 10.26% It
contains not less than 98.0 percent and not more than 102.0 percent of C17H20N4S
calculated with reference to the dried substance.
CHARACTERISTICS : A yellow
to light yellow, crystalline powder, odourless or almost odourless. SOLUBILITY
: Practically insoluble in water; sparingly soluble in acetonitrile, ethyl
acetate and soluble in chloroform. STORAGE
: Olanzapine should be protected from light. THERAPEUTIC
CATEGORY : Antipsychotic SPECIFICATION
OF OLANZAPINE
| DESCRIPTION
: | light
yellow to yellow crystalline powder | | SOLUBILITY
: | practically
insoluble in water, soluble in dichloro methane and chloroform |
| IDENTIFICATION
: | IR Absorption |
| MELTING
POINT : | Range
186 c to 196 c | | MOISTURE
CONTENTL: | Limit
0.5 % | | SULPHATED
ASH : | Limit
0.2 % | | HEAVY
METALS : | Limit
20ppm | | RESIDUAL
SOLVENTS : |
Ethyl Acetate | Limit
5000 ppm | | | Ethyl
Alcohol | Limit
5000 ppm | | | Acetonitrile | Limit
410 ppm | | |
Toluene | Limit
890 ppm | RELATED
SUBSTANCE ( HPLC ): | Single
Impurity | NMT
0.20 % | | | Total
Impurity | NMT
0.50 % | | PURITY
: | ( POTENTIOMETRIC
TITRATION ) | Limit
98.0 % TO 102.0 % | |