Transcript Reference standards1

Reference standards
Bujji Kanchi
Purpose
• Identification
• Quantification
Akbar wants to shorten the line
Using Reference standard line only,
We should compare and judge
How to Measure length ?
• Using a scale.
• Then, Scale is a Reference standard to
measure.
Do U want to measure weight of ?
In daily life, we use to buy things
by measuring against standard
weights
So, For every measurement, There needs a reference standard.
Hence for every quantification, Reference standard is required
for accuracy
Identification
• Any material is identified with its reference
standard.
• A material is compared against its reference
standard for Identity. Eg: IR
Types of Standards
• Reference standards are of two types
1. Primary Reference standards.
2. Secondary Reference standard
or working reference standard.
Primary Reference standards or
primary standards
• Primary standards are the chemical
substances which are accepted without
reference to other standards.
• No testing is required for primary reference
standard, directly it can be used with out
further testing in our lab.
Primary Reference standard
Pharmacopial or In-house
• Primary standard may be obtained from the
USP/NF or EP or BP and other official sources or
prepared by the manufacturer.
• If there is no official source to obtain material
(In-house products).
Primary std should be properly
identified.
• Primary standards are characterized for
proper identification by exclusive testing like
• IR
• NMR
• MASS
• UV/Vis
• CHN analysis
Evaluation of potency.
• %Potency = 100-All impurities(including water and residual solvents)
• If a standard requires drying, the required amount must be
transferred to a clean weighing bottle for drying.
• The weighing bottle must be protected from light during use. Dried
standards must not be returned to the original bottle in order to
avoid any possible contamination of the stock. After drying, place
the standard into the desiccator to equilibrate before assaying.
Working reference standard
• Pharmacopeial primary standards are costly
and single use only. We can not buy every
time.
• To over come this,
Instead of Primary standards, working
standard can be used.
Packing and labeling
• Pharmacopial PRS should be used directly for
any testing, No further packing is required.
• In-house PRS should be packed in 12 amber
color glass bottle for one year,
• Each bottle should be used for only one
month.
Packing and labelling
• This is a best practice to avoid attacking
Moisture from atmosphere for multiple use.
• Three buffer vials should be kept for sake of
spillage or customer requirement etc..
• Pack the working standard like In-house PRS
Packing for one year
• 12 containers+ 3 buffer containers
COA for PRS
• Pharmacopial standard does not provide COA
• Only certificate is provided.
• We should check that #
The current lot of primary standard should be
in place.
• In-house PRS should have COA.
USP Certificate
Working standard
• A working standard is a standard that is
qualified against and used instead of the
reference standard.
• There are generally used for regular analysis of
drug substances.
• Working standard becomes In-house.
• COA is prepared.
Retest or Expiration dating:
• The retest or expirations dating for primary
reference standards can be obtained from the
official source. In case of in-house reference
standards retest date can be assigned by the
stability and sensitivity of drug substance.
• In case of secondary standards, usually one year
is the retest period. This parameter always
depends on the stability of the drug substance.
Storage of Standards
• Working standards are stored in the same
manner as indicated by the official source or
stability of the standard and are stored in
amber glass containers, protected from light,
heat and moisture.
Storage of Standards
• Working standards should be kept at ambient
conditions in an amber dissector cabinet,
unless otherwise specified by the individual
monograph and if the standard that require
storage in a "cold" or "dry" place are to be
stored in a refrigerator at 2-8°C.
Working standard
• Working standard purity is verified
periodically, If it is been used for more than
one year.
• Even for Key starting materials, In-house PRS
must be evaluated and used.
• Select the batch for the working standard
qualification, which is highly pure.
Precautions
• Working standard can not be used for
qualifying another working standard
• Expired vials should not be used.
• Current lot should be used for Pharmacopial
standards
• Current lot of In-house standards should be in
place for every month
Correct labeling of vials
Inward and Consumption of
Pharmacopeial standard
• Inward should be maintained for each
purchase of standard .
• Usage log must be recorded.
Usage # Pharmacopial standards
Pharmacopial standards for Multiple use
Used for Identification Eg: MR standards.
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Pharmacopial standards for single use
Used for quantification
• Questions ?
Thank you