Omeprazole Magnesium EP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97.5 102.00% MAGNESIUM (ANHYDROUS BASIS) 3.3 355% WATER 7 10.00% ABSORBANCE @ 440 nm 0.1 RELATED SUBSTANCES TO PASS TEST TO PASS TEST...
Ondansetron Hydrochloride USP
Test Specification Min Max ASSAY (C[@18@]H[@19@]N[@3@]O.HCl; AHYDROUS BASIS) 98 102.00% WATER DETERMINATION 9 10.50% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0.10% ONDANSETRON RELATED COMPOUND D...
Oxytetracycline Hydrochloride EP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95.0 - 102.0 % 95.0 - 102.0 % pH OF A 1% SOLUTION 2.3 - 2.9 2.3 - 2.9 SPECIFIC OPTICAL ROTATION -188...
Orphenadrine Citrate USP
Test Specification Min Max ASSAY (C[@18@]H[@23@]NO??[@6@]H[@8@]O[@7@; DRIED BASIS] 98 101.50% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST ISOMER CONTENT TO PASS TEST ELEMENTAL IMPURITIES...
Norethindrone USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST MELTING RANGE 202?? 208?? SPECIFIC...
Niclosamide Anhydrous BP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% LOSS ON DRYING 0.50% SULFATED ASH 0.10% CHLORIDES 500 ppm 2-CHLORO-4-NITROANILINE 100 ppm 5-CHLOROSALICYLIC ACID 60 ppm RELATED SUBSTANCES TO PASS...
Neomycin Sulfate USP
Test Specification Min Max POTENCY (NEOMYCIN; DRIED BASIS) 600 ug/mg pH of a 33mg/ml Solution @ 25 C 5 7.5 LOSS ON DRYING 8.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Naltrexone Hydrochloride Dihydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% COMPLETENESS OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a][@D@] -187??to -197??/td> -187??to -197??/td> CHLORIDE (Cl) 9.2 9.58% WATER DETERMINATION AS REPORTED...
Naloxone Hydrochloride Dihydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% SPECIFIC ROTATION [a][@D@] -170??to -181??/td> -170??to -181??/td> CHLORIDE CONTENT (DRIED BASIS) 9.54 9.94% NOROXYMORPHONE HCl AND OTHER[nIMPURITIES TO PASS TEST LOSS...
Neostigmine Bromide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0% 98.0 - 102.0% MELTING RANGE 171 - 176 C (dec 171 - 176 C (dec LOSS ON DRYING 2.00% RESIDUE...
Naproxen USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION +83.0 to+89.5??/td> +83.0 to+89.5??/td> CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES: NICKEL...
Magnesium Salicylate Powder USP
Test Specification Min Max ASSAY 98 103.00% MAGNESIUM CONTENT 6.3 6.70% WATER DETERMINATION 17.5 21.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION...
Meclizine Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97.0 - 102.0 % 97.0 - 102.0 % WATER 5.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL...
Metoclopramide Hydrochloride Monohydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% WATER DETERMINATION 4.5 6.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES: N-ACETYLMETOCLOPRAMIDE ( METOCLOPRAMIDE RELATED CPD. A ) 0.15% METHYL 4-ACETAMIDO-2-METHOXYBENZOATE (...
Megestrol Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST MELTING RANGE WITHIN 3?? WITHIN 3?? SPECIFIC ROTATION [a][@D@] +8.8??to +12.0 +8.8??to...
Mometasone Furoate USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 102.0 % 97.0 - 102.0 % SPECIFIC ROTATION, [a][@D@]25 +56??to +62??/td> +56??to +62??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...
Methylprednisolone Sodium Succinate USP
Test Specification Min Max ASSAY (C[@26@]H[@33@]NaO[@8@]; DRIED BASIS) 97 103.00% SPECIFIC ROTATION +96??to +104??/td> +96??to +104??/td> SODIUM (DRIED BASIS) 4.49 4.77% LOSS ON DRYING 3.00% IDENTIFICATION TO PASS TEST TO...
Metformin Hydrochloride BP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST IMPURITY F TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50%...
Metronidazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...
Methotrexate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% RELATED COMPOUNDS TO PASS TEST ENANTIOMERIC PURITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER...
Methocarbamol USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...
Lovastatin USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.0 % 98.5 - 101.0 % SPECIFIC ROTATION +324 to +338 +324 to +338 LOSS ON DRYING 0.30% CHROMATOGRAPHIC PURITY TO...
Levonorgestrel USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% ETHYNYL GROUP 7.81 8.18% MELTING RANGE (WITHIN 4??) 232?? 239?? SPECIFIC ROTATION, [a][@D@]25 -30??to -35??/td> -30??to -35??/td> RESIDUE ON IGNITION 0.30%...
Lincomycin Hydrochloride Monohydrate USP
Test Specification Min Max ASSAY 790 ug/mg 790 ug/mg SPECIFIC ROTATION [a][@D@] +135 to +150 +135 to +150 CRYSTALLINITY TO PASS TEST TO PASS TEST pH OF A 1 IN...
Losartan Potassium USP
Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT-FREE BASIS) 98.5 101.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER DETERMINATION 5.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION DATE OF...
Lisinopril USP
Test Specification Min Max ASSAY (C[@21@]H[@31@]N[@3@]O[@5@]; ANHYDROUS BASIS) 98 102.00% SPECIFIC ROTATION -115.3 to -122.5 -115.3 to -122.5 WATER DETERMINATION 8 9.50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...
Lansoprazole USP
Test Specification Min Max ASSAY (C[@16@]H[@14@]F[@3@]N[@3@]O[@2@]S) 98 102.00% RESIDUE ON IGNITION 0.10% WATER DETERMINATION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION...
Ketoprofen USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 92 97.0?? SPECIFIC ROTATION [a][@D@] +1 to -1??/td> +1 to -1??/td> LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS...
Indomethacin USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO PASS TEST...
Imipramine Hydrochloride USP
Test Specification Min Max ASSAY (C[@19@]H[@24@]N[@2@][-HCl; DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION...
Indapamide USP
Test Specification Min Max ASSAY (C[@16@]H[@16@]CIN[@3@]O[@3@]S; DRIED BASIS) 98 101.00% LOSS ON DRYING @ 105 C 3.00% RESIDUE ON IGNITION 0.10% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST IDENTIFICATION...
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.