Compendial Method Testing

 

 

Compendial Method Testing

 

Galbraith Laboratories provides much of the monograph testing as found in the United States Pharmacopoeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), Food Chemicals Codex (FCC), and ACS Reagent Chemicals. Galbraith also performs some standards included in AOAC, AOCS, Standard Methods, TAPPI, EPA, and ASTM.

Monograph testing may include assay testing, purity testing, limit testing, identification, and physical properties testing. The analysis of full monographs is available with a 15 business day turnaround time (7 business days for rush).

Some compendia such as USP, EP, and JP require performance verification for all procedures that are not basic compendial test procedures such as loss on drying, residue on ignition, various wet chemical procedures such as acid value, and simple instrumental determinations such as pH measurements. Galbraith maintains a library of previously verified procedures and offers method verification services for new materials.

Below are some examples of tests we perform. If you so not see the one you need, please contact us for more information.


 

Example USP-NF General Chapters

<191> Identification Tests
<401> Fats and Fixed Oils
<197> Spectrophotometric Tests
<461> Nitrogen Determination
<201> Thin-Layer Chromatography
<467> Residual Solvents
<206> Aluminum
<631> Color and Achromicity
<211> Arsenic
<643> Total Organic Carbon
<221> Chloride and Sulfate
<645> Water Conductivity
<232>/<233> Elemental Impurities
<731> Loss on Drying
<241> Iron
<733> Loss on Ignition
<251> Lead
<781> Optical Rotation
<261> Mercury
<791> pH
<271> Readily Carbonizable Substances
<841> Specific Gravity
<281> Residue on Ignition
<921> Water Determination
<291> Selenium
<191> Identification Tests
<197> Spectrophotometric Tests
<201> Thin-Layer Chromatography
<206> Aluminum
<211> Arsenic
<221> Chloride and Sulfate
<232>/<233> Elemental Impurities
<241> Iron
<251> Lead
<261> Mercury
<271> Readily Carbonizable Substances
<281> Residue on Ignition
<291> Selenium
<401> Fats and Fixed Oils
<461> Nitrogen Determination
<467> Residual Solvents
<631> Color and Achromicity
<643> Total Organic Carbon
<645> Water Conductivity
<731> Loss on Drying
<733> Loss on Ignition
<781> Optical Rotation
<791> pH
<841> Specific Gravity
<921> Water Determination

Example Compendial Monograph Materials

Acetone
Dextrose (D-Glucose)
Polyethylene Glycol 3350
Alcohol
Dibasic Potassium Phosphate
Polymyxin B Sulfate
Aluminum Chlorohydrate
Dibasic Sodium Phosphate
Polysorbate 20
Aluminum Hydroxide Gel
Dimethyl Sulfoxide
Polysorbate 80
Aluminum Potassium Sulfate
Edetate Disodium
Potassium Acetate
Aluminum Sesquichlorohydrate
Ephedrine Sulfate
Potassium Hydroxide
Aluminum Zirconium Tetrachlorohydrex Gly
Ethyl Acetate
Potassium Iodide
Ammonium Carbonate
Eucalyptus Oil
Potassium Sorbate
Ammonium Sulfate
Ferrous Gluconate
Povidone
Amphotericin B
Gentamicin Sulfate
Proline
Arginine
Glacial Acetic Acid
Propylene Glycol
Arginine Hydrochloride
Glycerin
Saccharin Sodium
Barium Sulfate
Glycine
Salicylic Acid
Bendamustine HCl
Histidine
Silicon Dioxide
Benzalkonium Chloride (or Solution)
Histidine Phosphate
Sodium Acetate
Benzethonium Chloride
Hydrochloric Acid
Sodium Alginate
Benzyl Alcohol
Hydroxyethyl Cellulose
Sodium Ascorbate
Biotin
Hydroxypropyl Betadex
Sodium Bicarbonate
Boric Acid
Hypromellose
Sodium Carbonate
Bupivacaine Hydrochloride
Isoleucine
Sodium Chloride (or injection)
Butylated Hydroxyanisole
Isopropyl Alcohol
Sodium Citrate
Calcium Acetate
Leucine
Sodium Fluoride
Calcium Carbonate
L-Glutamine
Sodium Hydroxide
Calcium Chloride
Lidocaine
Sodium Lactate Solution
Calcium Citrate
Lincomycin HCl
Sodium Metabisulfite
Calcium Gluconate
Liquefied Phenol
Sodium Thiosulfate Pentahydrate
Calcium Pantothenate
Lomustine
Sterile Water for Injection
Calcium Propionate
Lysine Hydrochloride
Streptomycin Sulfate
Calcium Sulfate
Magnesium Chloride
Strong Ammonia Solution
Camphor
Magnesium Oxide
Sulfuric Acid
Carbomer Homopolymer
Magnesium Sulfate
Taurine
Castor Oil
Medium-Chain Triglycerides
Temozolomide
Cefazolin
Meglumine
Thiamine Hydrochloride
Cefoxitin Sodium
Meloxicam
Titanium Dioxide
Chlorhexidine Gluconate Solution
Menthol
Trehalose
Chloroxylenol
Methionine
Triclosan
Cholesterol
Methylparaben
Tromethamine
Ciprofloxacin
Monobasic Potassium Phosphate
Tryptophan
Ciprofloxacin Hydrochloride
Monobasic Sodium Phosphate
Urea
Citric Acid Anhydrous (or Monohydrate)
Monothioglycerol
Urea Powder
Citric Acid Monohydrate
Niacin (nicotinic acid)
Valine
Colloidal Silicon Dioxide
Novobiocin Sodium
Vancomycin Hydrochloride
Cupric Sulfate
Olive Oil
Vitamin E
Cyanocobalamin
Pentetic Acid
Vitamin E Polyethylene Glycol Succinate
Cysteine Hydrochloride
Peppermint Oil
White Petrolatum
Deferoxamine Mesylate
Phenylalanine
Zinc Chloride
Dehydrated Alcohol
Poloxamer 188
Zinc Sulfate
Dental-Type Silica
Polyethylene Glycol
 
Acetone
Alcohol
Aluminum Chlorohydrate
Aluminum Hydroxide Gel
Aluminum Potassium Sulfate
Aluminum Sesquichlorohydrate
Aluminum Zirconium Tetrachlorohydrex Gly
Ammonium Carbonate
Ammonium Sulfate
Amphotericin B
Arginine
Arginine Hydrochloride
Barium Sulfate
Bendamustine HCl
Benzalkonium Chloride (or Solution)
Benzethonium Chloride
Benzyl Alcohol
Biotin
Boric Acid
Bupivacaine Hydrochloride
Butylated Hydroxyanisole
Calcium Acetate
Calcium Carbonate
Calcium Chloride
Calcium Citrate
Calcium Gluconate
Calcium Pantothenate
Calcium Propionate
Calcium Sulfate
Camphor
Carbomer Homopolymer
Castor Oil
Cefazolin
Cefoxitin Sodium
Chlorhexidine Gluconate Solution
Chloroxylenol
Cholesterol
Ciprofloxacin
Ciprofloxacin Hydrochloride
Citric Acid Anhydrous (or Monohydrate)
Citric Acid Monohydrate
Colloidal Silicon Dioxide
Cupric Sulfate
Cyanocobalamin
Cysteine Hydrochloride
Deferoxamine Mesylate
Dehydrated Alcohol
Dental-Type Silica
Dextrose (D-Glucose)
Dibasic Potassium Phosphate
Dibasic Sodium Phosphate
Dimethyl Sulfoxide
Edetate Disodium
Ephedrine Sulfate
Ethyl Acetate
Eucalyptus Oil
Ferrous Gluconate
Gentamicin Sulfate
Glacial Acetic Acid
Glycerin
Glycine
Histidine
Histidine Phosphate
Hydrochloric Acid
Hydroxyethyl Cellulose
Hydroxypropyl Betadex
Hypromellose
Isoleucine
Isopropyl Alcohol
Leucine
L-Glutamine
Lidocaine
Lincomycin HCl
Liquefied Phenol
Lomustine
Lysine Hydrochloride
Magnesium Chloride
Magnesium Oxide
Magnesium Sulfate
Medium-Chain Triglycerides
Meglumine
Meloxicam
Menthol
Methionine
Methylparaben
Monobasic Potassium Phosphate
Monobasic Sodium Phosphate
Monothioglycerol
Niacin (nicotinic acid)
Novobiocin Sodium
Olive Oil
Pentetic Acid
Peppermint Oil
Phenylalanine
Poloxamer 188
Polyethylene Glycol
Polyethylene Glycol 3350
Polymyxin B Sulfate
Polysorbate 20
Polysorbate 80
Potassium Acetate
Potassium Hydroxide
Potassium Iodide
Potassium Sorbate
Povidone
Proline
Propylene Glycol
Saccharin Sodium
Salicylic Acid
Silicon Dioxide
Sodium Acetate
Sodium Alginate
Sodium Ascorbate
Sodium Bicarbonate
Sodium Carbonate
Sodium Chloride (or injection)
Sodium Citrate
Sodium Fluoride
Sodium Hydroxide
Sodium Lactate Solution
Sodium Metabisulfite
Sodium Thiosulfate Pentahydrate
Sterile Water for Injection
Streptomycin Sulfate
Strong Ammonia Solution
Sulfuric Acid
Taurine
Temozolomide
Thiamine Hydrochloride
Titanium Dioxide
Trehalose
Triclosan
Tromethamine
Tryptophan
Urea
Urea Powder
Valine
Vancomycin Hydrochloride
Vitamin E
Vitamin E Polyethylene Glycol Succinate
White Petrolatum
Zinc Chloride
Zinc Sulfate