Reset Search
 

 

Article

Elemental Impurities Information for Avantor Excipient Products

« Go Back

Information

 
Question
Do you have Elemental  Impurities information per USP General Chapters <232> and <233> for your excipient products?  
Answer
We have begun to generate information for our excipient products. Please see links below. As we generate more information, this list will be updated.
Elemental Impurities (ppm) for the following Pharmaceutical Substances:
 
Acetic Acid 36% 
Acetic Acid 80%
Acetic Acid, Glacial 
Acetone
Ammonium Hydroxide, Strong 
Ammonium Sulfate
Ammonium Sulfate (4628)
Benzyl Alcohol
Benzyl Alcohol (9039) 
Boric Acid
Butylparaben
Calcium Acetate
Calcium Chloride Dihydrate
Citric Acid, Anhydrous 
Citric Acid, Monohydrate 
Dextrose (Glucose) Anhydrous
Dextrose (Glucose) Monohydrate
Dilute Hydrochloric Acid
Diluted Phosphoric Acid 
Edetate Disodium
Ethyl Acetate
Ethylparaben
Galactose
Glycerin
Glycine
Guanidine Hydrochloride
Hydrochloric Acid
Hydrochloric Acid 1.0N 0325
Isopropyl Alcohol
Lactic Acid
Lactose Monohydrate
L-Alanine
L-Arginine
L-Arginine HCl
L-Aspartic Acid
L-Cysteine Monochloride Monohydrate
Glutamic Acid
L-Glutamine 
L-Histidine
L-Histidine Hydrochloride Monohydrate
Liquid Phenol 
L-Isoleucine 
L-Leucine 
L-Lysine Monohydrochloride 
L-Methionine
L-Phenylalanine
L-Proline
L-Serine 
L-Threonine 
L-Tryptophan
L-Tyrosine
L-Valine
Magnesium Stearate
Mannitol 
MES 
Methyl Alcohol
Methylparaben
Mineral Oil (Heavy) 
Mineral Oil (Light)
MOPS 
Nitric Acid
Phenol, Crystal
Phenol, Fused
Phosphoric Acid
Polysorbate 20
Polysorbate 20 Super Refined 
Polysorbate 80
Polysorbate 80 Super Refined 
Potassium Bicarbonate
Potassium Chloride 
Potassium Chloride (3045)
Potassium Hydroxide Pellets
Potassium Phosphate Dibasic
Potassium Phosphate Monobasic
Propylparaben
Sodium Acetate Anhydrous
Sodium Acetate Trihydrate
Sodium Benzoate 
Sodium Bicarbonate
Sodium Chloride 
Sodium Citrate Dihydrate
Sodium Citrate Dihydrate 0734
Sodium Hydroxide 1.0 N 
Sodium Hydroxide 10 N
Sodium Hydroxide Pellets 
Sodium Phosphate Dibasic Anhydrous 
Sodium Phosphate Dibasic Heptahydrate 
Sodium Phosphate Monobasic Monohydrate 
Sorbitol
Stearic Acid
Sucrose
Sucrose (Beet Derived)
Sucrose (Cane Derived)
Sulfuric Acid
Talc
Tartaric Acid
Thiamine Hydrochloride
Tromethamine
Urea
 

Please be aware that if you are using an older version of Adobe Acrobat Reader (5.0 or earlier, for example) the information in the attached files may not display correctly. If needed, you can visit the Adobe homepage to download the most current version of the Adobe Reader software free of charge: Adobe.com
  
 
  
 Trademarks are owned by Avantor Performance Materials, LLC. or its affiliates unless otherwise noted.
 2017 Avantor Performance Materials, LLC.
 
File 
KeywordsHeavy metals, Metals, Impurities, Elemental

Feedback

 

Was this article helpful?


   

Feedback

Please tell us how we can make this article more useful.

Characters Remaining: 255