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3.Nervous System Agents:

3.1.Levodopa
Standard: BP2002, USP 24, EP4; GMP Approved; DMF Available

Molecular formula: C9H11NO4 Molecular weight: 197.19

Appearance: white or slightly cream crystalline powder, odorless

Identification: I.R: positive

Solubility: meets the requirements

pH: 4.5 ~ 7.0

Color of solution: meets the requirements

Organic volatile impurity: meets the requirements

Light absorption: 137 ~ 147o

Optical rotation (BP2002): -1.27 ~ -1.34o

Specific rotation (USP24): -160 ~ -167o

Heavy metals (BP2002): 10ppm max., USP24 20ppm max.

Related substances (BP2002): meets the requirements

3-(3,4,6-Trihydroxyphenyl) alanine (USP24): 0.1% max.

3-Methoxytyrosine (USP24): 0.5% max.

Loss on drying: 1.0% max.

Residue on ignition: 0.10% max.

Residual solvent: Ethanol: 1.0% max.

Assay (on dry basis): 99.0~101.0%

3.2.Gabapentin
Standard: USP 29; GMP Approved; DMF Available

Appearance: white or off-white powder

IR: conforms with spectrum of USP Gabapentin RS

HPLC: conforms with the RT of the major peak in HPLC with USP Gabapentin RS

pH: 6.5 ~ 8.0

Water: 0.5% max.

Residue on ignition: 0.1% max.

Limit of chloride: 0.01% max.

Heavy metals: 0.002% max.

Residual solvents: toluene 0.05% max., ethanol 0.20% max.

Gabapentin related components:

A: 0.10% max.

Any unknown impurity: 0.10% max.

Total impurities: 0.50% max.

Assay: 98.0~102.0%

3.3.Methyldopa
GMP Approved; DMF Available

Appearance: white or almost white, or almost colorless crystalline powder

Identification: A, B, C, D: positive

Solubility: meets the requirements

Appearance of solution: not more colored than BY6 or B6

Absorption: 122 ~ 137

Acidity (0.1N NaOH): 0.50ml/g max.

Specific rotation: -25.0 ~ -28.0o

Optical rotation: -1.10 ~ -1.23o

Residue on ignition: 0.10% max.

Heavy metals: 10ppm max.

Water: 10.0% ~ 13.0%

Residual solvents: meets the requirements

Related substances:

a) 3-o-methyl methyldopa and related substance: 0.50% max.

b) Any unknown impurity: 0.10% max.

c) Total impurities: 2.0% max.

d) Assay: 98.5% ~ 101.0%

3.4.Hydroxyzine Hcl
USP 28 GMP Approved DMF Available

Molecular formula: C21H27ClN202.2HCl Molecular weight: 447.83

Appearance: white or almost white crystalline powder

Identification: A), B), C): positive

Loss on drying: 5.0% max.

Residue on ignition: 0.5% max.

Heavy metals: 20ppm max.

Organic volatile impurities: meets the requirements

Individual impurity: 0.3% max.

Total impurities: 1.5% max.

Solubility: very easily soluble in water, soluble in chloroform

Assay: 98.0 ~ 100.5%

3.5.Sulpiride
GMP Approved DMF Available COS Approved Standard: EP5, JP14

Molecular formula: C15H23N3O4S Molecular weight: 341.43

White or almost white crystalline powder

Melting point: 177 ~ 181oC

IR absorption: concordant with the reference spectrum

Fluorescence test: show blue fluorescence

Appearance of solution: not more than reference solution Y6

TLC related substance: 0.1% max.

HPLC related substance: 0.3% max.

Chloride: 0.01% max.

Iron: 0.001% max.

Heavy metals: 0.001% max.

Loss on drying: 0.5% max.

Sulfated ash: 0.1% max.

Assay (on dry basis): 98.5 ~ 101.0%

Microbiological purity: Bacteria: 1000cfu/g max.

Molds and yeasts: 100CFU/g max.

Escherichia coli: absent

3.6.Diphenidol Hcl
Standard: JP13,JP14 GMP Approved

Molecular formula: C21H27NO HCL Molecular weight: 345.91

Appearance: white crystalline powder

Identification: positive

Melting point: about 217oC

pH: 4.7 ~ 6.5

Arsenic: 1ppm max.

Related substances: meets the requirements

Heavy metals: 20ppm max.

Loss on drying: 0.5% max.

Sulphated ash: 0.1% max.

Assay: 98.5% min.

3.7.Carbamazepine
GMP Approved DMF Available

Molecular Formula: C15H12N2O Molecular weight: 236.27

Appearance: white or almost white crystalline powder

Solubility: meets the requirements

Identification: I.R: positive

Melting point: 189~193oC

Acidity: 0.5ml max.

Alkalinity: 1.0ml max.

Related substances:

A1(TLC): 0.1% max. (IDB)

A2 (TLC): 0.01% max. (single max.)

B1(HPLC): 0.2% max. (single, max.)

B2 (HPLC): 0.5% max. (total)

Heavy metals: 20ppm max.

Loss on drying: 0.5% max.

Sulfated ash: 0.1% max.

Assay (on the dry basis): 97.0~103.0%