Solubility of Active Materials in Water

In this section, the solubilities of over 200 active pharmaceutical ingredients (APIs) are presented. The matrix shows the extent of solubility of the most commonly used APIs in the manufacture of medicines. Again, the purpose of this matrix is to help in the selection of worst-case products, containing these APIs for cleaning validation, based on their solubility in water or alcohol.

Active Ingredients

Solubility in Water

Activated attapulgite

Insoluble in water

Amphotericin

Practically insoluble in water, soluble in alcohol

Acyclovir

Soluble in water

Acebutolol hydrochloride

Freely soluble in water and in alcohol

Acetazolamide

Very slightly soluble in water, slightly soluble in alcohol

Albendazole

Insoluble in water and in alcohol

Aluminum hydroxide

Practically insoluble in water

Alprostadil

Practically insoluble in water, freely soluble in alcohol

Alprenolol hydrochloride

Very soluble in water, freely soluble in alcohol

Amantadine hydrochloride

Freely soluble in water and in alcohol

Amiodarone

Very slightly soluble in water

Ammonium chloride

Freely soluble in water

Amoxicillin

Slightly soluble in water

Ampicillin trihydrate

Slightly soluble in water, practically soluble in alcohol

Amikacin sulfate

Freely soluble in water

Aminophylline

Freely soluble in water

Aspirin

Insoluble in water, freely soluble in alcohol

Astemizole

Practically insoluble in water

Atropine sulfate

Very soluble in water

Atenolol

Sparingly soluble in water, soluble in ethanol

Azithromycin dihydrate

Practically insoluble in water, freely soluble in ethanol

Betamethasone valerate

Practically insoluble in water, soluble in alcohol

Bacitracin USP

Freely soluble in water, soluble in alcohol

Bacampicillin hydrochloride

Soluble in water

Bisacodyl

Insoluble in water, sparingly soluble in alcohol

Beclomethasone dipropionate

Very slightly soluble in water, freely soluble in alcohol

Betaxolol hydrochloride

Very soluble in water, freely soluble in alcohol

Bezafibrate

Practically insoluble in water, sparingly soluble in methanol

Benzalkonium chloride

Very soluble in water and in alcohol

Benzocaine

Very slightly soluble in water

Bifonazole

Practically insoluble in water

Bromocriptine mesylate

Practically insoluble in water

Active Ingredients

Solubility in Water

Budesonide

Practically insoluble in water, sparingly soluble in alcohol

Buprenorphine hydrochloride

Sparingly soluble in water

Bufexamac

Practically insoluble in water

Bupivacaine hydrochloride

Soluble in water, freely soluble in alcohol

Calcium pantothenate

Insoluble in water

Caffeine

Freely soluble in boiling water

Carbamazepine

Very slightly soluble in water

Captopril

Freely soluble in water and in methanol

Carbidopa

Slightly soluble in water, very slightly soluble in alcohol

Carbachol

Very soluble in water, sparingly soluble in alcohol

Cetylpyridinium chloride

Very soluble in water

Calcitriol

Practically insoluble in water, freely soluble in alcohol

Calcium ascorbate

Freely soluble in water, practically insoluble in alcohol

Cinnarizine theophyllinate

Practically insoluble in water, freely soluble in CH2Cl2

Clobetasol propionate

Practically insoluble in water, sparingly soluble in ethanol

Cephalexin monohydrate

Slightly soluble in water, practically insoluble in alcohol

Cefaclor monohydrate

Soluble in water, insoluble in methanol

Cefixime

Slightly soluble in water

Cefazolin sodium

Freely soluble in water, very slightly soluble in alcohol

Ceftazidime

Slightly soluble in water

Cefuroxime axetil

Slightly soluble in water, soluble in methanol

Cefotaxime

Freely soluble in water

Ceftriaxone

Freely soluble in water, sparingly soluble in methanol

Cetirizine HCl

Freely soluble in water

Cephradine

Sparingly soluble in water

Chlorpheniramine maleate

Freely soluble in water

Chlorambucil

Practically insoluble in water, freely soluble in ethanol

Chloramphenicol

Slightly soluble in water, freely soluble in alcohol

Chlorcyclizine hydrochloride

Freely soluble in water, soluble in alcohol

Chlorhexidine

Miscible in water, soluble in alcohol

Chlorpromazine

Practically insoluble in water, freely soluble in ethanol

Ciclopirox

Slightly soluble in water, freely soluble in ethanol

Cimetidine

Slightly soluble in water, soluble in alcohol

Ciprofloxacin

Sparingly soluble in water, slightly soluble in alcohol

Clarithromycin

Practically insoluble in water, slightly soluble in dehydrated alcohol

Clavulanate potassium

Freely soluble in water, soluble in methanol

Clobutinol HCl

Freely soluble in water and in alcohol

Codeine phosphate

Freely soluble in water, soluble in ethanol

Colchicine

Very soluble in water

Cloxacillin sodium

Freely soluble in water and in methanol

Cyanocobalamin

Sparingly soluble in water and in alcohol

Cyclosporine

Practically insoluble in water, soluble in methanol

Dextromethorphan HBr

Sparingly soluble in water

Diphenhydramine HCl

Very soluble in water, freely soluble in alcohol

Diflunisal

Practically insoluble in water, soluble in alcohol

Diclofenac diethylamine

Sparingly soluble in water, freely soluble in methanol

Diethycarbamazine citrate

Very soluble in water, soluble in alcohol

Active Ingredients

Solubility in Water

Dexpanthenol

Freely soluble in water and in alcohol

Diazepam

Very slightly soluble in water, soluble in alcohol

Dimenhydrinate

Slightly soluble in water, freely soluble in alcohol

Diphenoxylate HCl

Sparingly soluble in water

Doxycycline hyclate

Soluble in water, slightly soluble in alcohol

Ephedrine HCl

Freely soluble in water, soluble in ethanol

Enalapril maleate

Soluble in water

Erythromycin

Practically insoluble in water, soluble in methanol

Etodolac

Practically insoluble in water, freely soluble in ethanol

Famotidine

Very slightly soluble in water, slightly soluble in methanol

Felodipine

Practically insoluble in water, freely soluble in ethanol

Fenoprofen calcium

Slightly soluble in water, soluble in methanol

Fluxetine HCl

Sparingly soluble in water, freely soluble in alcohol

Fluticasone propionate

Practically insoluble in water, slightly soluble in ethanol

Folic acid

Practically insoluble in water

Fluvoxamine maleate

Sparingly soluble in water, very soluble in methanol

Flutamide

Practically soluble in water, freely soluble in alcohol

Fusidic acid

Practically insoluble in water, freely soluble in alcohol

Flunitrazepam

Practically insoluble in water, slightly soluble in alcohol

Flutamide

Practically insoluble in water, freely soluble in alcohol

Fluvoxamine maleate

Sparingly soluble in water

Ferrous sulfate (dried)

Freely soluble in water, very soluble in boiling water

Ferrous fumarate

Slightly soluble in water, very slightly soluble in alcohol

Furosemide

Practically insoluble in water, sparingly soluble in alcohol

Gemfibrozil

Practically insoluble in water, freely soluble in methanol

Ginseng

Freely soluble in water

Glibenclamide

Insoluble in water, slightly soluble in alcohol

Gliclazide

Practically insoluble in water, slightly soluble in alcohol

Glycerin

Soluble in water and in alcohol

Glyceryl guaiacolate

Freely soluble in water

Gramicidin

Insoluble in water

Heparin calcium

Freely soluble in water

Hydrocortisone

Insoluble in water, slightly soluble in alcohol

Hyoscine-N-butyl bromide

Freely soluble in water, sparingly soluble in ethanol

Ibuprofen

Practically insoluble in water

Indapamide

Insoluble in water, soluble in alcohol

Indomethacin

Practically insoluble in water, sparingly soluble in alcohol

Kaopectate

Insoluble in water

Ketotifen fumarate

Slightly soluble in water, sparingly soluble in methanol

Ketoconazole

Practically insoluble in water, soluble in methanol

Lacidipine

Practically insoluble in water, sparingly soluble in ethanol

Lomefloxacin HCl

Slightly soluble in water

Loratadine

Insoluble in water, soluble in methanol

Levofloxacin

Levofloxacin

Lidocaine HCl

Very soluble in water, freely soluble in alcohol

Magnesium aluminum silicate

Insoluble in water and in alcohol

Active Ingredients

Solubility in Water

Magnesium hydroxide

Miconazole nitrate

Mebendazole

Menthol

Metronidazole

Metoclopramide HCl

Metformin HCl

Nifedipine

Nicotinamide

Norfloxacin

Nystatin topical

Neomycin sulfate

Omeprazole

Orphenadrine citrate

Orciprenaline sulfate

Orphenadrine hydrochloride

Oxazepam

Oxybuprocaine HCl

Oxymetazoline HCl

Oxytetracycline

Paracetamol

Papaverine hydrochloride Paroxetine HCl hemihydrate Penicillamine Pentoxifylline Phenobarbital sodium Phenylephrine HCl Phenylalanine Piperazine citrate Propranolol HCl Prazosin hydrochloride Prednisolone Promethazine HCl Procaine hydrochloride Proxyphylline Pheniramine maleate Pseudoephedrine HCl Ranitidine HCl

Recombinant human erythropoietin

Resorcinol

Rifampicin

Risperidone

Salbutamol sulfate

Salicylamide

Salicylic acid

Sertaconazole nitrate

Silver sulfadiazine

Practically insoluble in water Slightly soluble in water Practically insoluble in water Insoluble in water

Sparingly soluble in water and in alcohol

Very soluble in water, freely soluble in ethanol

Freely soluble in water, slightly soluble in alcohol

Practically insoluble in water

Freely soluble in water

Slightly soluble in water

Insoluble in water

Freely soluble in water

Freely soluble in water and in alcohol

Sparingly soluble in water, slightly soluble in ethanol

Freely soluble in water and in alcohol

Freely soluble in water and in alcohol

Practically insoluble in water, slightly soluble in alcohol

Very soluble in water, freely soluble in alcohol

Freely soluble in water and in ethanol

Freely soluble in water, sparingly soluble in alcohol

Freely soluble in alcohol, soluble in boiling water

Sparingly soluble in water, slightly soluble in alcohol

Slightly soluble in water, freely soluble in methanol

Freely soluble in water, slightly soluble in alcohol

Soluble in water

Freely soluble in water, soluble in alcohol Freely soluble in water

Sparingly soluble in water, very slightly soluble in alcohol Freely soluble in water, practically insoluble in alcohol Soluble in water

Very slightly soluble in water, slightly soluble in alcohol

Very slightly soluble in water, Soluble in methanol

Very soluble in water, freely soluble in alcohol

Very soluble in water, soluble in alcohol

Very soluble in water, soluble in alcohol

Very soluble in water, freely soluble in alcohol

Very soluble in water

Very soluble in water, moderately soluble in alcohol

Sparingly soluble in water

Very soluble in water and in alcohol

Slightly soluble in water, soluble in methanol

Practically insoluble in water, sparingly soluble in alcohol

Freely soluble in water

Slightly soluble in water

Slightly soluble in water, freely soluble in alcohol Practically insoluble in water, soluble in methanol Insoluble in water and in alcohol

Active Ingredients

Solubility in Water

Simvastatine sodium

Practically insoluble in water, freely soluble in methanol

Sodium alendronate

Soluble in water, very slightly soluble in methanol

Sodium citrate

Freely soluble in water

Sodium valproate

Very soluble in water, slightly to freely soluble in water

Sodium iodide

Very soluble in water, freely soluble in alcohol

Somatostatin

Freely soluble in water

Simethicone

Practically insoluble in water

Sucralfate

Insoluble in water

Succinylsulfathiazole

Very slightly soluble in water, slightly soluble in alcohol

Tamoxifene citrate

Very slightly soluble in water, soluble in methanol

Tetracycline HCl

Soluble in water

Theophylline

Slightly soluble in water, sparingly soluble in alcohol

Tribenoside

Very soluble in water and in alcohol

Triamcinolone acetonide

Insoluble in water

Triprolidine HCl

Soluble in water and in alcohol

Trimethoprim

Very slightly soluble in water, slightly soluble in alcohol

Tyrothricin

Practically insoluble in water, soluble in alcohol

Xylometazoline

Soluble in water

Vancomycin HCl

Freely soluble in water

Verapamil hydrochloride

Soluble in water, freely soluble in methanol

Vitamin A

Insoluble in water

Vitamin D

Insoluble in water

Vitamin C

Freely soluble in water

Vitamin Bj

Sparingly soluble in water

Vitamin B2

Soluble in water

Vitamin B6

Freely soluble in water

Vitamin Bj2

Sparingly soluble in water

Xylometazoline hydrochloride

Freely soluble in water, alcohol, and methanol

Zinc oxide

Insoluble in water

Solubility Key Solubility Scale in Numbers

Very soluble in water 1

Freely soluble in water 2

Soluble in water 3

Sparingly soluble in water 4

Slightly soluble in water 5

Very slightly soluble in water 6

Practically insoluble in water or insoluble 7

Was this article helpful?

0 0
Naturally Cure Erectile Dysfunction

Naturally Cure Erectile Dysfunction

Whether we like it or not, for many men it gets increasingly difficult to perform sexually as the years advance.

Get My Free Ebook


Post a comment