Albendazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...
Aspartame Powder FCC
Test Specification Min Max ASSAY (C[@14@]H[@18@]N[@2@]O[@5@]; DRIED BASIS) 98 102.00% OPTICAL ROTATION, [a] 20D (DRIED BASIS) +14.5??to +16.5 +14.5??to +16.5 5-BENZY-3,6-DIOXO-2-PIPERAZINEACETIC ACID (RELATED COMPOUNDS A) 1.50% OTHER RELATED IMPURITIES 2.00%...
Amoxicillin Trihydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 900 1050 ??/mg CRYSTALLINITY TO PASS TEST pH OF A 0.2% SOLUTION 3.5 6 WATER DETERMINATION 11.5 14.50% DIMETHYL ANILINE TO PASS TEST...
Sorbitan Sesquioleate NF
Test Specification Min Max ASSAY (FATTY ACIDS) 74 80.00% ASSAY (POLYOLS; w/w) 22 28.00% HYDROXYL VALUE 182 220 SAPONIFICATION VALUE 143 165 FATTY ACID COMPOSITION TO PASS TEST TO PASS...
Agar Powder FCC
Test Specification Min Max ARSENIC (As) 3 mg/kg ASH (ACID-INSOLUBLE) 0.50% ASH (TOTAL) 6.50% GELATIN TO PASS TEST TO PASS TEST INSOLUBLE MATTER 1.00% LEAD (Pb) 5 mg/kg LOSS ON...
Ammonium Carbonate Powder NF
Test Specification Min Max ASSAY (NH[@3@]) 30 34.00% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.00% SULFATE 0.01% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST CERTIFIED KOSHER CERTIFIED...
L-Asparagine Monohydrate FCC
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.50% OPTICAL ROTATION, [a] 20D +33.0??to +36.5 +33.0??to +36.5 LOSS ON DRYING 11.5 12.50% LEAD (Pb) 5 mg/kg RESIDUE ON IGNITION 0.10%...
Sodium Alendronate EP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0% 98.0 - 102.0% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH OF SOLUTION 4.0 - 5.0 4.0 -...
Aminocaproic Acid USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 101.50% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE...
Amiodarone Hydrochloride EP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH 3.2 3.8 RELATED SUBSTANCES TO PASS TEST TO PASS TEST IMPURITY...
Chloramphenicol Palmitate USP
Test Specification Min Max ASSAY (C[@11@]H[@12@]Cl[@2@]N[@2@]O[@5@]) 555 - 595 ??/mg 555 - 595 ??/mg MELTING RANGE 87??- 95?? 87??- 95?? SPECIFIC ROTATION, [a] (C=5;ANHYD. ALCOHOL) +21??to +25??/td> +21??to +25??/td> CRYSTALLINITY...
DL-Menthol Crystal FCC
Test Specification Min Max SPECIFIC ROTATION, [a][@D@]25 -2??to +2??/td> -2??to +2??/td> RESIDUE AFTER EVAPORATION 0.05% READILY OXIDIZABLE SUBSTANCES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS...
Agar Granular NF
Test Specification Min Max BOTANICAL CHARACTERISTICS AS REQUIRED AS REQUIRED MICROBIAL LIMITS TO PASS TEST TO PASS TEST WATER DETERMINATION 20.00% TOTAL ASH (DRIED BASIS) 6.50% ACID INSOLUBLE ASH (DRIED...
Phenylephrine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION @25 C -43??to -47??/td> -43??to -47??/td> LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% SULFATE 0.20% ELEMENTAL IMPURITIES AS...
Adipic Acid FCC
Test Specification Min Max ASSAY (C[@6@]H[@10@]O[@4@]) 99.6 101.00% MELTING RANGE 151.5 154 C WATER 0.20% LEAD (Pb) 2 mg/kg RESIDUE ON IGNITION 0.00% IDENTIFICATION TO PASS TEST TO PASS TEST...
Polysorbate 40 FCC
Test Specification Min Max ASSAY (OXYETHYLENE, ANHYDROUS BASIS) 66.0 - 70.5 % 66.0 - 70.5 % HYDROXYL VALUE 90 - 107 90 - 107 SAPONIFICATION VALUE 41 - 52 41...
D-Galactose cGMP Manufactured
Test Specification Min Max SPECIFIC ROTATION +78.0??to +81.5 +78.0??to +81.5 ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST WATER DETERMINATION...
D-(+)-Trehalose Dihydrate cGMP Manufactured
Test Specification Min Max APPEARANCE TO PASS TEST TO PASS TEST APPEARANCE/COLOR OF SOLUTION TO PASS TEST TO PASS TEST ASSAY (HPLC, ANHYDROUS) 97 102.00% pH (10% AQUEOUS) 4.5 6.5...
Anhydrous Dibasic Calcium Phosphate Powder USP
Test Specification Min Max ASSAY 98 103.00% LOSS ON IGNITION 6.6 8.50% ACID-INSOLUBLE SUBSTANCES 0.20% CARBONATE TO PASS TEST TO PASS TEST CHLORIDE (Cl) 0.25% FLUORIDE 0.01% SULFATE 0.50% ARSENIC...
Bismuth Subnitrate Powder USP
Test Specification Min Max ASSAY (Bi[@2@]O[@3@]; DRIED BASIS) 79.00% 79.00% LOSS ON DRYING 3.00% CARBONATE (CO[@3@]) TO PASS TEST TO PASS TEST CHLORIDE (Cl) 0.04% SULFATES (SO[@4@]) TO PASS TEST...
Nicotine Polacrilex 20 Percent USP
Test Specification Min Max ASSAY (C[@10@]H[@14@]N[@2@]; ANHYDROUS BASIS) 19 23% NICOTINE RELEASE 70 % of total 70 % of total WATER DETERMINATION 5.00% ORGANIC IMPURITIES TO PASS TEST TO PASS...
Propantheline Bromide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% BROMIDE (Br) 17.5 18.20% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED...
L-Proline FCC
Test Specification Min Max ASSAY (C[@5@]H[@9@]NO[@2@]; DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, [a]D20 (DRIED BASIS) -84.0??to -86.3 -84.0??to -86.3 LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.30% RESIDUE ON IGNITION...
Ampicillin Trihydrate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 900 - 1050 ug/mg 900 - 1050 ug/mg CRYSTALLINITY TO PASS TEST DIMETHYLANILINE TO PASS TEST pH (1% SOLUTION) 3.5 - 6.0 3.5...
Methimazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM (Se) 30 ppm ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL...
Calcium Chloride Anhydrous Pellets FCC
Test Specification Min Max ASSAY 93.0 - 100.5 % 93.0 - 100.5 % ACID-INSOLUBLE SUBSTANCES 0.02% ARSENIC (As) 3 mg/kg FLUORIDE 0.00% LEAD (Pb) 5 mg/kg MAGNESIUM AND ALKALI SALTS...
Copper Gluconate USP
Test Specification Min Max ASSAY 98 102.00% CHLORIDE 0.07% SULFATE 0.05% ARSENIC 3 ppm LEAD 25 ug/g REDUCING SUBSTANCES (as DEXTROSE) 1.00% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...
Sulfuric Acid 66 DEG Be FCC
Test Specification Min Max ASSAY 91 - 95 % 91 - 95 % ARSENIC (As) 3 mg/kg CHLORIDE (Cl) 0.01% IRON (Fe) 0.02% LEAD (Pb) 5 mg/kg NITRATE (NO[@3@]) 10...
Sulfuric Acid 50 Percent (w/w) Solution FCC
Test Specification Min Max ASSAY 49.0 - 51.0 % 49.0 - 51.0 % ARSENIC (As) 3 mg/kg CHLORIDE (Cl) 0.01% IRON (Fe) 0.02% LEAD (Pb) 5 mg/kg NITRATE (NO[@3@]) 10...
Tartaric Acid Granular FCC
Test Specification Min Max ASSAY (C[@4@]H[@6@]O[@6@]; DRIED BASIS) 99.7 100.50% OPTICAL ROTATION, [a] 25D +12.0??to +13.0 +12.0??to +13.0 LEAD 2 mg/kg LOSS ON DRYING 0.50% OXALATE TO PASS TEST RESIDUE...
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