Bulk API

Erythromycin is in a group of drugs called macrolide antibiotics.

Molecular C37H67NO13
Molecular Weight 733.93 g/mole
Chemical Name (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane- 2,10-dione
CAS# 114-07-8
AbbVie US Drug Master File (DMF) U.S. DMF # 84774
Packaging 500 kilogram high density polyethylene drums with polyethylene bag liners and security seal
Sample available: 50 grams
Test Name Acceptance Criteria
Moisture (by KF) ≤ 6.5%
Crystallinity Exhibits birefringence and extinction positions
Thiocyanate ≤ 0.3%
Identification (by IR) Sample and standard spectra are qualitatively identical except region between 1980 reciprocal cm and 2050 reciprocal cm
Appearance Powder and/or crystals
Color White to slightly yellow
Identifications (EP) Passes test requirements
Ery A+B+C (Anhydrous, by HPLC, EP) 93.8 – 102.0%
Use STM.0022300 to calculate
Ery B (As Is, by HPLC, EP) ≤ 5.0%
Ery C (As Is, by HPLC, USP/EP) ≤ 5.0%
Ery A Enol Ether (As Is, by HPLC, USP/EP) ≤ 3.0%
Largest Single Impurity (As Is, by HPLC, USP/EP) ≤ 3.0%
Ery A+B+C (Anhydrous, by HPLC, USP) 88.0 - 100.5%
Use STM.0022300 to calculate
Ery B (As Is, by HPLC, USP) ≤ 12.0%
Total Impurities (As Is, by HPLC, EP) ≤ 7.0%
Specific Rotation (USP) -78 to -71 degrees
Between -78 and -71 degrees, calculated on the anhydrous basis
Amyl Acetate (by GC) ≤ 3000 ppm
Amyl Alcohol (by GC) ≤ 500 ppm
Methylene Chloride (by GC) ≤ 600 ppm
Sulphated Ash (EP/BP) / Residue on Ignition (USP) ≤ 0.2%
Total Aerobic Microbial Count by Pour-Plate Method ≤ 2000 CFU/g
Total Yeast and Mold Count by Pour-Plate Method ≤ 200 CFU/g