Ibuprofen USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED CHROMATOGRAPHIC IMPURITIES TO PASS TEST IBUPROFEN RELATED COMPOUND C 0.10%...
Hyoscyamine Sulfate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% SPECIFIC ROTATION [a][@D@] -24??to -29??/td> -24??to -29??/td> WATER DETERMINATION 2.5 5.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL...
Hyoscyamine USP
Test Specification Min Max ASSAY 98.0-101.0 % 98.0-101.0 % MELTING RANGE 106 - 109 C 106 - 109 C SPECIFIC ROTATION, [a][@D@](C = 1) -20 to-23 -20 to-23 LOSS ON...
Hydralazine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH (1 in 50) 3.5 4.2 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED HYDRAZINE 0.00% ORGANIC...
Hydroxyprogesterone Caproate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% MELTING RANGE 120??- 124?? 120??- 124?? SPECIFIC ROTATION +58??to +64??/td> +58??to +64??/td> WATER DETERMINATION 0.10% FREE n-CAPROIC ACID 0.58% ORDINARY IMPURITIES...
Granisetron Hydrochloride EP
Test Specification Min Max ASSAY 97 102.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH OF SOLUTION 4 6.5 LOSS ON DRYING 0.50% IMPURITY E 0.50% RELATED SUBSTANCES...
Gliclazide BP
Test Specification Min Max APPEARANCE White or almost White or almost ASSAY (DRIED SUBSTANCE) 99.0 - 101.0 % 99.0 - 101.0 % RELATED SUBSTANCES TO PASS TEST TO PASS TEST...
Fludrocortisone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] 126?? 138??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 3.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS...
Glipizide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.40% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS TO PASS TEST IDENTIFICATION TO...
Gemfibrozil USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST WATER DETERMINATION 0.25% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO PASS TEST EXPIRATION DATE...
Glycopyrrolate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ERYTHRO ISOMER 0.40% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES...
Griseofulvin Micronized BP EP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST SPECIFIC OPTICAL ROTATION +354??to +364??/td> +354??to +364??/td> ACIDITY TO PASS TEST TO...
Famotidine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...
Fluocinonide Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION +81??to +89??/td> +81??to +89??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Ethinyl Estradiol Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% COMPLETENESS OF SOLUTION TO PASS TEST MELTING RANGE 180?? 186?? SPECIFIC ROTATION [a][@D@] -28.0??to-29.5 -28.0??to-29.5 LOSS ON DRYING 1.00% IDENTIFICATION TO...
Fluocinolone Acetonide Anhydrous Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +98??to +108??/td> +98??to +108??/td> LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...
Estrone USP
Test Specification Min Max ASSAY (C[@18@]H[@22@]O[@2@]; DRIED BASIS) 97 103.00% CLARITY OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a]D25 +158??to +165??/td> +158??to +165??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION...
Epinephrine Bitartrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% MELTING RANGE 147 152?? LOSS ON DRYING 0.50% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ADRENALONE TO PASS TEST NOREPINEPHRINE BITARTRATE 4.00% ELEMENTAL...
Estriol Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% COMPLETENESS OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a]D25 +54??to +62??/td> +54??to +62??/td> CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST...
Ethacrynic Acid USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% EQUIVALENT WEIGHT (DRIED BASIS) 294 309 RESIDUE ON IGNITION 0.10% LOSS ON DRYING 0.25% HEAVY METALS 0.00% TOLUENE EXTRACTIVES 2.00% IDENTIFICATION...
Ether For Anesthesia USP
Test Specification Min Max ASSAY 96 98.00% SPECIFIC GRAVITY @ 25[dC 0.713 0.716 ACIDITY (as CH[@3@]COOH) 0.00% NONVOLATILE RESIDUE 0.00% ALDEHYDE TO PASS TEST PEROXIDE 0.3 ppm LOW BOILING HYDROCARBONS...
Erythromycin Estolate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 600 ug/g 600 ug/g CRYSTALLINITY TO PASS TEST TO PASS TEST WATER 4.00% FREE ERYTHROMYCIN 3.00% IDENTIFICATION TO PASS TEST TO PASS TEST...
Dexchlorpheniramine Maleate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a]D25 +39.5 to +43.0??/td> +39.5 to +43.0??/td> pH OF A 1% SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE...
Dexamethasone Acetate Anhydrous Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +82??to +88??/td> +82??to +88??/td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.40% RESIDUE ON IGNITION 0.10% ELEMENTAL...
Diphenhydramine Hydrochloride USP
Test Specification Min Max ASSAY 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION...
Diltiazem Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] +110??to +116??/td> +110??to +116??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES...
Diflunisal USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.50% LOSS ON DRYING 0.30% CHROMATOGRAPHIC PURITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED...
Diazoxide USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED RESIDUE ON IGNITION 0.10% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE...
Disulfiram USP
Test Specification Min Max ASSAY 98 102.00% MELTING RANGE 69??- 72?? 69??- 72?? RESIDUE ON IGNITION 0.10% SELENIUM 30 ppm IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE...
Active Pharmaceutical Ingredients
Chemical APIs (Active Pharmaceutical Ingredients)
Spectrum Chemical manufactures and distributes over 400 chemical APIs (active pharmaceutical ingredients. These substances are the biologically active component of any drug product regardless of pharmaceutical formulation type (tablets, capsules, topical, etc.). Spectrum Chemicals Australia specializes in providing the top active pharmaceutical ingredients for at least 40 therapeutic areas . All Spectrum Chemical active pharmaceutical ingredients are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities. Spectrum’s pledge to you is our products will be delivered to you with the quality and delivery you can count on every time. contact us.