INDICES> Sodium bicarbonate with EDTA Sodium

[Mukasa Fred <production.jms@imul.com>]

INDICES> Sodium bicarbonate with EDTA Sodium
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Greetings from Kampala

In the production unit of Joint Medical Store, we also produce products
like Sodium bicarbonate IV 8.4%. 

This is the formulation:
Sodium bicarbonate     84 g
Sodium edetate         100 mg
Water for injection ad 1000 ml

After dissolving, filtering and autoclaving under sterile conditions,these
are the observations:
Out of a batch of 200 5-ml vials, about 5 turn to brown colour.
In all the 200 vials, there are tiny white particles which dissolve in
water and cannot be isolated

Questions:

Is EDTA Sodium a suitable chelating agent for Sodium bicarbonate solution?
Can EDTA Sodium (salt) be interchanged with EDTA (an acid) and in which
propotions?

Might heat during autoclaving be responsible for the observations noted above?

How can I obtain a clear solution without particles?

Waiting for your assistance.

Fred Mukasa
production pharmacist
JMS
Uganda 
Email: production.jms@imul.com

[please add email to your signature; thanks WB]
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