Near to Expire API

suppose we have Metformin Hcl going to expire on 20/8/2020,can we use to form a batch of product from this on 19/8/2020.?
and product expiry is 2 yrs mean in 2022

Kindly give feed back
@Ankur ch
@Meenakshi Gupta

Any guidelines relating the use of API 1 or 2 day before expiry date.if retest date is not given ?

Product can’t exceed the expiry date of raw material.

Its practice that people use API few days before its expiration and make a product which have 2 or 3 yrs of expiration date.

Wrong practice, it can never be done.

We need a clear reference regarding this point

The practice which I saw is that described by Dr. Sajjad

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Any inactive can be used as per above mentioned condition but a API can not.
Any API expiry should not be less then the product expiry

sr kindly can u provide any guidelines.bcz i have same point as u but when people ask for guidelines i have not that


I made a “quick” search now and did not find any reference which mentions this point

So I think that the current seen practice holds till now

im searching from last couple of days but didn’t find

You can find it in paragraph 14.2 of following FDA document
@Sajjad_Ahmad, @Awad @Ravi.yadav770

i provide this same to my fellows but their main point is that its for expired API n 1 day befor if we use that API then its not expired

I have already seen this FDA document during my quick search and did not find a useful information regarding our issue

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I have extensively searched for it in FDA, WHO and ICH guidelines but It is not mentioned anywhere that near to expiry raw materials can’t be used in the formulation. Some guidelines say to retest the near to expiry raw materials but that is stated for API manufacturers.

Even no FDA warning letter is issued for using near to expiry raw material or any related issue. It shows that near to expiry raw material can be used after retest.

But we must use it carefully because only passing results in a retest of API is not enough to use it in the formulation.
The expiry of any API is determined mainly by the assay and degradation products. If both are within the limit then you can use that API in the formulation. But if any of these results are close to limit then it would not be good to use the same in the formulation.
For example:
Assay limit: NLT 98.5%
Degradation Products limit: MNT 1.0%
If this API has an expiry date of 3 years and now 2 months are remaining in expiration.
After retest if results are Assay = 98.8% and Degradation products = 0.90%
In such conditions, we can’t use it in the formulation of a product having an expiry date for 2 years because for the next two years API will not comply with the specification.
If you are using near to expiry raw material then you must have sufficient scientific data to prove that it will comply during the entire shelf life of the formulated product.
I think it is clear now.
@Sajjad_Ahmad @Awad @Ravi.yadav770


thanks sr
its make some concept

There is a last option which I can suggest to Dr. Sajjad

EMA , WHO , FDA can be asked via internet (and I have asked them before regarding other issues and they replied to me)

I suggest that Dr. Sajjad formulates a clear question regarding our issue and send it to the following links and emails then inform us with the answers which will reach him.
Note that EMA is committed to reply to received questions within not more than 2 months

EMA link for asking questions:

FDA email for asking Quality questions:
[email protected]

WHO quality assurance representatives and their emails:

Dr Sabine Kopp
[email protected]

Ms Sinéad Jones
[email protected]

Ms Claire Vogel
[email protected]

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ok thanks bro i will send the query

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