dear friends,
heparin injection which is in liquid form is generally filled in type -1 vials what will happen if i go for type-111 vials,if it will effect the quality of the product then in what way & if any one having a study report on it then please provide.
kindly waiting for your valuable suggestions
my email id
kapoorv90@yahoo.in
Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties.
Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.
The ph of Heparin Sodium injection is 5.0-7.5 which can be adjusted with hydrochloric acid or sodium hydroxide.
Type -1 glass is a neutral galss or Boroscillicate glass having high hydrolytic ressitance and can withstand any pH and offers product stability.
Type -III glass is soft glass or sodalime glass.
"We should not fill any liquid products into that.Used only for dry products that are immediately reconstitued and used also for Oily preperations.
If you make Heparin in this the stability changes and causes serious adverse reactions to patients like profuse bleeding.
[quote=durga prasad]heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties.
Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.
The ph of heparin sodium injection is 5.0-7.5 which can be adjusted with hydrochloric acid or sodium hydroxide.
Type -1 glass is a neutral galss or boroscillicate glass having high hydrolytic ressitance and can withstand any ph and offers product stability.
Type -iii glass is soft glass or sodalime glass.
"we should not fill any liquid products into that.used only for dry products that are immediately reconstitued and used also for oily preperations.
If you make heparin in this the stability changes and causes serious adverse reactions to patients like profuse bleeding.[/quote]
thanks durga prasad for your reply
i was just thinking that soda lime treated vials are being leached when they come in contact with aqueous phase of injection & this can effect the stability of the product.
And when i explained this to my superiors they asked me weather iam having any data regarding this explanation.
Regarding data I would suggest you look the properties of Type-III glass. In this it is clearly written as “NOT FOR LIQUID PREPERATIONS”.
From the day you fill HEPARIN in to type-III vial it starts deteriorating.
You identify manufacturers with in your country ,buy 2 or 3 samples from the market, examine those vials too. You can have an idea to enlighten your superiors and show them.
[quote=DURGA PRASAD]Regarding data I would suggest you look the properties of Type-III glass. In this it is clearly written as “NOT FOR LIQUID PREPERATIONS”.
From the day you fill HEPARIN in to type-III vial it starts deteriorating.
You identify manufacturers with in your country ,buy 2 or 3 samples from the market, examine those vials too. You can have an idea to enlighten your superiors and show them.[/quote]
thanks dear friend for your response & support
please explin me the logic of the following thing
our company purchased heparine sodium 7000 mega with the potency of 150 iu/mg on asis basis
when the supplier was asked about this low potency he told even though the potency is low we are providing you excess material which will compensate the low potency of the material.
and also please tell me how much kg will be in 7000 mega of the material