SR.NO TEST SPECIFICATION RESULT1 Description White to off White Powder. Off White Powder2 Soluble Soluble in Methanol. Complies3 Identification IR absorption spectophotometry comparison :amlodipine Base CRS Complies4 Melting Point 1320C to 1380C 1320C5 Water Not more than 1.0 % 0.91 %6 Related Substance[By HPLC] 1. Impurity D : Not More Thane 0.3 %2. Total Of other Impurities At RRT 0.65 :Not More Thane 0.3 %3. Total Impurities : Not More Thane 0.6 %[Excluding impurity D]4. Highest unknown Impurity : Not More Thane 0.3 % Complies7 Assay [By HPLC]On anhydrous basis. Not less than 97.0 % ww and not more than 101.0% ww on anhydrous basis 99.6%

Sr. No. TEST OBSERVATION S SPECIFICATIONS1 Description Almost white powder. White or almost white powder .2 Solubility Slightly soluble in water , Freely soluble in Methanol & Slightly soluble in IPA Slightly soluble in water , Freely soluble in Methanol & Slightly soluble in IPA3 Identifications A. The IR spectrum of the substance is concordant with the IR spectrum obtained from Amlodipine Besilate working standardB. The UV absorption spectrum of the substance being examined is exhibit the wavelength maxima as that of Amlodipine Besilate working standard. A.The IR spectrum of the substance being examined must be concordant with the IR spectrum obtained from Amlodipine Besilate working standard
B. The UV absorption spectrum of the substance being examined should exhibit the wavelength maxima as that of Amlodipine Besilate working standard..4 Optical Rotation (ODB) ( 1% in Methanol) +0.004. Between -0.10and +0.10.5 Water content ( By KF ) 0.41% NMT 0.50%6 Sulphated Ash 0.10% NMT 0.20% 7 Related substances By TLC Complies Any spot , apart from the principle spot is not more intense than the spot obtained with reference solution ( 0.30%) 8 Related SubstancesBy HPLC
0.08%0.12%0.06%0.20%0.15%0.68%
Impurity : A NMT : 0.30% Impurity : B NMT : 0.30%Impurity : C NMT : 0.30%Impurity : D NMT : 0.30% Any other individual impurity : NMT 0.3%Total impurities: NMT 1.0% 9 Assay by HPLC(On anhydrous basis) 99.5 % NLT 97.0% and NMT102.0% ww

Remarks: The product complies as per In-House-BP specification.

Sr no. ITEMS STANDARD RESULTS1. Characteristics white powder complies2. Identification positive reaction positive reaction3. Water 5.0%8.0% 7.1%4. Acidity or alkalinity meets the requirements complies5. Assay for penicillin 96.0%102.0% 98.1%6. Benzathine content 24.0%27.0% 26.5%7. Bacterial endotoxins meets the requirements complies8. Sterility meets the requirements complies9. Related substances meets the requirements compliesConclusion: Conforms to the standards of BP2001.

Sr. No. TEST OBSERVATION S SPECIFICATIONS1 Description White crystalline powder. White to almost white crystalline powder.2 Solubility Soluble in water, very slightly soluble in methanol. Practically insoluble in MDC. Soluble in water, very slightly soluble in methanol. Practically insoluble in MDC.3 Identifications A. The IR spectrum of the substance is concordant with the IR spectrum obtained from Sodiun Alendronate working standardB. Complies A.The IR spectrum of the substance being examined must be concordant with the IR spectrum obtained from Sodiun Alendronate working standard
B. Sodium test should be positive.4 Loss on drying 16.6% Between 16.1% to 17.1 %5 Heavy metals Complies NMT 10 ppm.6 pH ( 1% in CO2 free water ) 4.6 Between 4.0 to 5.0Appearance of the solution Complies 1.0% solution in water should be clear & not more intensely coloured than reference solution B7 or BY7. 7 4-Amino Butanoic acid by TLC Complies NMT 0.5% 8 Phosphate & phosphate By HPLC
0.32%0.28%0.19%0.89%
Impurity : A NMT : 0.50% Impurity : B NMT : 0.50%Any other individual impurity : NMT 0.5%Total impurities: NMT 1.5% 9 Assay by HPLC(On anhydrous basis) 99.1 % NLT 98.0% and NMT102.0% ww

Remarks: The product complies as per In-House-BP specification.

Sr. No. TEST OBSERVATION S SPECIFICATIONS1 Description Yellow crystalline powder. Yellow crystalline powder.2 Solubility Freely soluble in Acetone & Chloroform. Practically insoluble in water. Freely soluble in Acetone & Chloroform. Practically insoluble in water.3 Identifications A. The IR spectrum of the substance is concordant with the IR spectrum obtained from Nifedipine working standardB. 172.6 C to 173.8C A.The IR spectrum of the substance being examined must be concordant with the IR spectrum obtained from Nifedipine working standard
B. Melting range between 171C & 175C.4 Loss on drying 0.29% NMT 0.50%5 Heavy metals Complies NMT 10 ppm.6 Sulphated Ash 0.08% NMT 0.10% 7 Related substances By TLC Complies Any spot , apart from the principle spot is not more intense than the spot obtained with reference solution ( 0.20%) 8 Related SubstancesBy HPLC
0.05%0.11%0.09%0.25%
Impurity : A NMT : 0.20% Impurity : B NMT : 0.20%Any other individual impurity : NMT 0.3%Total impurities: NMT 1.0% 9 Assay by Titrematry(On anhydrous basis) 99.4 % NLT 98.0% and NMT102.0% ww

Remarks: The product complies as per In-House-IP specification.Note : Store in dry place, light resistant container.

No Test Specification Results1 Description A White Crystalline Powder White Powder2 IDENTIFICATION (A) By IR As Per USP 28 Complies As per Raptakos Report No. D0601060 (B) Melting Point Between 157 C 167C 160C - 161C(C) Test for Sodium As Per USP 28 CompliespH 7.2 - 8.3 7.83 Water Not More Than 4.5% 2.12%4 Heavy Metal Not More Than 0.001% Complies As per Raptakos Report No. D0601060 5 Absorbance in alkaline Solution Absorbance Not More Than 0.1 0.0826 Chromatographic Purity As Per USP 28 Complies Any Impurity - Not More Than 0.3% NilTotal Impurity- Not More Than 1.0% Nil7 OVI As Per USP 28 As per Raptakos Report No. D0601060 Methylene Chloride NMT 600 ppm NilChloroform NMT60 ppm 4.58 ppmTrichloro ethylene NMT 80 ppm Nil1, 4 Dioxane NMT 380 ppm Nil8 Assay Not Less Than 97% & Not More Than 102% on anhydrous & IPA Free basis 99.64% As per Raptakos Report No. D0601060

ITEMS STANDARD RESULT
Appearance Brown crystalline powder Conform
Loss on drying 6.0%8.0% 7.06%
Melting point 187192 188.3189.9 Assay 98.0101.0% 98.9%
Residue in ignition 0.1%max 0.1%

white powder

white powder

white powder

white powder

Appearance:colorless transparent liquidContent of C5H8O4:99.0%(GC)Content of water:0.1%

Quality index:Appearance: colorless or yellowish transparent liquidContent of C9H16O4:96.0%(GC)Content of water:0.1%

Synonyms: p-Acetanisole; p-Acetylanisole; 4[-Methoxyacetophenone; 4'-Methoxyacetophenone; Acetanisole;
Mol. Formula: C_{9H10O2
Cas no: 100-06-1 Comment: LIGHT SENSITIVE. White to pale yellow crystals Mol. wt: 150.1768 Melting Point: 38 deg C Boiling Point: 152 - 154 at 26 mm Hg}

Cas no: 7306-46-9

Sr. No. TEST OBSERVATION SPECIFICATION1 Description Almost white powder White or almost white powder2 Solubility Freely soluble in MDC, Soluble in Methanol & very slightly soluble in Hexane& Water. Freely soluble in MDC, Soluble in Methanol & very slightly soluble in Hexane& Water.3 IdentificationsA By I.R.

B. Melting range A. The IR spectrum of the substance is concordant with the IR spectrum obtained from Amiodarone HCl working standardB. 159.9 C to 162.1C A.The IR spectrum of the substance being examined must be concordant with the IR spectrum obtained from Amiodarone HCl working standard
B. Melting range between 158C & 164C.4 Loss on drying 0.30% NMT 0.50% (w/w)5 Heavy metals Complies NMT 20 ppm.6 pH ( 1% solution in water 80C) 3.57 Between 3.2 & 3.87 Appearance of the solution Complies 1% solution in Methanol is not more intense than that of reference solution GY5.8 Iodide Complies NMT 150 ppm9 Sulphated ash 0.07% NMT 0.10% (w/w)10 Related substances By TLC Complies - Any spot , apart from the principle spot is not more intense than the spot obtained with reference solution ( 0.5%) - Any spot corresponding to (2-chloroethyl)diethylamine is not more intense than the spot obtained with reference solution ( 0.2%) 11 Related SubstancesBy HPLCAny other individual impurity :Total impurities:
0.16%0.35%
Any other individual impurity : NMT 0.50%Total impurities: NMT 1.00% 12 Assay by Titremetry(On anhydrous basis) 99.5 % NLT 98.5% and NMT101.0% w/w
Remarks: The product complies as per In-House-specification.Note : Store in dry place, light resistant container.

Item Specification ResultAppearance Yellowy crystalline powder Conforms Specific rotation -94-103 -96.5Clarity 2# <2#Dextroisomer 0.5% 0.3%Relative substances 0.25% 0.1%Loss on drying 3.0% 2.5%Residue on ignition 0.2% 0.04%Heavy metals 20ppm <20ppmAssay 98.5% 99.3%Foreign matter 2.0/g <2/gConclusion Conforms

Quality index:Appearance: colorless or yellowish oil liquidContent of C10H16O5:99.0%(GC)