MOLCHLOR® BKC

Benzalkonium Chloride Solution

(Antiseptic / Preservative)

benzalkonium-chloride-bp
MOLCHLOR® BKC is commonly known as Benzalkonium Chloride Solution. It is used as a preservative in ophthalmic multidose formulations at a safe and effective concentration.

MOLCHLOR® BKC

by Muby Chem

benzalkonium-chloride-bp-intro

Benzalkonium Chloride Solution

Muby Chem operates a state-of-the-art manufacturing facility producing Benzalkonium Chloride Solution known for its exceptional purity and efficacy.

Our advanced manufacturing technology ensures high-quality Benzalkonium Chloride Solution, meeting stringent performance and consistency standards.

Applications: MOLCHLOR® BKC is primarily used as a preservative in ophthalmic formulations, maintaining sterility and extending product shelf life in multidose containers. It is widely incorporated in glaucoma treatments, corticosteroid eye drops and general ophthalmic preparations to prevent microbial contamination during repeated use. In some cases, diluted Benzalkonium Chloride solutions are used for surface disinfection or instrument cleaning, although such applications are limited due to potential cytotoxicity. While highly effective as a preservative, prolonged exposure in ophthalmic use may lead to ocular surface irritation, especially in chronic therapy.

We follow Good Manufacturing Practices (GMP) and adhere to international regulatory standards to ensure quality consistency with continuous supply.

SPECIFICATION

#TESTSPECIFICATION - USP
1 Description It occurs as clear liquid, colorless or slightly yellow unless a colour has been added.
2 Identification
Test (A)
Test (B)
Test (C)
Test (D)
(A) A white precipitate is formed and is dissolved after adding 5 mL of alcohol.
(B) It gives reaction of chloride.
(C) An orange-red colour is produced.
(D) Chromatographic identity.
3 Limit of amines and amine salts Specified test.
4 Limit of Benzyl alcohol, Benzaldehyde and (Chloromethyl) Benzene.
(A) Benzyl alcohol
(B) Benzaldehyde
(C) (Chloromethyl) Benzene

(A) Not more than 0.5%.
(B) Not more than 0.15%.
(C) Not more than 0.05%.
5 Acidity and Alkalinity Specified test.
6 Microbial Test
(A) TAMC
(B) TYMC
(A) Not more than 103 cfu/g.
(B) Not more than 102 cfu/g.
8 BET Not more than 5 IU/mg.
9 Assay
(A) Ratio of Alkyl components
(A) For n-C12H25 homolog not less than 40.0%.
(B) For n- C14H29 homolog not less than 20.0% of the total alkylbenzyldimethylammonium chloride.
(C) for n-C12H25 and n- C14H29 homolog together is not less than 70.0% of total alkylbenzyldimethylammonium chloride content (calculated on anhydrous basis).
10 (B) Total alkylbenzyldimethylammonium chloride
(i) For labeled concentrations of not less than 1.0%
(i) For labeled concentrations of not less than 1.0%


(i) Not less than 95.0% to not more than 105.0%.

(ii) Not less than 93.0% to not more than 107.0%.

PACKAGING

MOLCHLOR® BKC is packed in HDPE drum or IBC packing having bar coded label.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserve in a tightly closed container.

ACCREDITATIONS

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health canada
edqm1
edqm
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ANVISA
sfda
saphra
tga
china
mhra
cdsco
who
eu
exci
ecovadis

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