Allotment of Lot numbers to volumetric solutions, buffer solutions, test solutions, HPLC mobile phases and Primary standards

1.0	OBJECTIVE :
	To  provide  the  procedure  for  allotting  lot  numbers  to  volumetric solutions,
	buffer  solutions, test  solutions, HPLC mobile phases and Primary standards.
	This system helps in identifying the solutions used in Analytical Development
	laboratories.
2.0	RESPONSIBILITY :
2.1	Analytical Development officer whoever prepares these solutions to allot the lot number.
2.2	AR&D Manager to ensure compliance.
3.0	PROCEDURE :
3.1	Volumetric Solutions
3.1.1	Prepare  volumetric  solutions as mentioned in the General Test Procedure of
	respective  volumetric solution  and  allot  a   separate   lot  number   for   each
	volumetric solution.
3.1.2	The   lot   number   shall   indicate   code   of   respective   volumetric   solution
	(annexure - 1), normality/molarity value, N/M (normality/molarity), serial number
	in sequential order and restandardization number in sequential order.
3.1.3	For example,  the lot number for 0.5N hydrochloric acid prepared first time
	and standardized first time shall be ADHA(0.5N)01-00.
3.1.4	The same solution if restandardized, the lot number shall be given as
	ADHA(0.5N)01-01.
3.1.5	The same solution if restandardized for second time the lot number shall be
	given as ADHA(0.5N)01-02.
3.1.6	Refer Annexure -1 for code of  various volumetric solutions.
3.1.7	The lot number for 0.5M H2SO4 prepared and standardized for first time
	shall be ADSA(0.5M)01-00

3.1.8	Serial number shall start from 01 for each individual volumetric solution every
	new year (1st January)
3.1.9	Each volumetric solution shall have expiration date. Expiration periods for
	various volumetric solutions mentioned in annexure -1.
3.1.10	Each volumetric solution shall be labelled (annexure -5) after preparation and
	standardization.
3.1.11	Each  volumetric  solution  shall  be  restandardized on the day of use.
3.1.12	Enter the details of preparation and standardization of volumetric solution
	in "Record of Analysis". (Annexure - 2)
3.2	pH Buffer Solutions :
3.2.1	Prepare  pH  Buffer  Solutions  as  mentioned  in  the General Test procedure
	"pH" and allot a separate lot number for each individual pH buffer solution.
3.2.2	The lot number indicate shortform of the buffer solution (BS), pH value and
	serial number in sequential order.
3.2.3	For  example, lot  number  for  pH  4.0  buffer  prepared  first  time  shall  be
	ADBS(4.0)01.
3.2.4	The  same  buffer  if  prepared  second  time the lot number shall be given as
	ADBS(4.0)02.
3.2.5	For  example, lot  number  for  pH  7.0 buffer  prepared  first  time  shall  be
	ADBS(7.0)01.
3.2.6	Similarly, lot number for pH 9.2 buffer prepared first time shall be ADBS(9.2)01.
3.2.7	The serial number shall start from 01 for each individual buffer solution every
	new year (1st January).
3.2.8	Enter the details of preparation of buffer solution in "Record of Analysis"
	(Annexure - 3).

3.2.9	Each buffer solution shall be labelled (Annexure -4) after preparation.
3.3.10	Buffer solutions shall be used within 8 days from the day of preparation.
3.3	Test Solutions
3.3.1	Test  solutions  include indicators, colorimetric solutions, test solutions and
	any other solutions except volumetric solutions, Buffer solutions and HPLC
	mobile  phase. Prepare  test  solutions  as  mentioned in Monographs and
	allot reference number for each individual test solutions.
3.3.2	Reference number is A.R.Number in case of R&D samples analysis, Experiment number
	in case of Analytical Method development experiments,Validation protocol number
	in case of Analytical method validation.
3.3.3	Enter  the  details  of  preparation  of  test  solutions  in worksheets in case of R&D
	samples analysis, in registers in case of method development and method validation.
	The label shall contain the details like Name, Date of preparation, Use before date,
	Prepared by and reference number.
3.3.4	Each test solution shall be labelled (Annexure - 4) after preparation.
3.3.5	Test solution shall be used within 30 days from the day of preparation, unless
	otherwise specified in the individual monograph.
3.4	HPLC Mobile Phases :
3.4.1	Prepare HPLC mobile phase as mentioned in monographs/STPs and allot a
	reference number for each individual mobile phase.
3.4.2	Reference number of mobile phase shall be AR No. incase of R&D support
	group, Experimental No. incase of method development, validation protocol No.
	incase of method validation
3.4.3	Each HPLC mobile phase shall be labelled (Annexure - 4) after preparation.
3.4.4	Prepare HPLC mobile phase fresh before use.

3.4.5	Record the mobile phase preparations in respective worksheets, in case of
	R&D support group, in the Validation Registers in case of Method Validation group, in
	the Experimental Register in case of Method development.
3.5	Primary Standards :
3.5.1	Primary standards used for standardizing volumetric solutions, preparation of
	pH buffers, preparation of limit test standard solutions, Colorimetric solutions
	etc.,  shall be dried in a shallow weighing bottle at specified temperature and
	for specified time as mentioned in the respective GTP/STP.
3.5.2	The primary standards after drying, shall be cooled to room temperature in
	a desiccator.
3.5.3	Dried primary standards shall be opened for a minimum time while using.
	After use they shall be replaced in the desiccator.
3.5.4	Each primary standard dried shall be given a lot number.
3.5.4.1	Primary standard lot number shall consists of seven characters.
3.5.4.2	The first two characters are ADPS indicating primary standard.
3.5.4.3	The  next three characters  indicate  the  serial  number  in  sequential  order
	starting from 001 every new year (1st January).
	E.g.. : The first primary standard dried  in year '97 shall be given Lot Number
	as ADPS001.
3.5.5	Enter the details of drying in "Primary standard drying register" (annexure -6)
3.5.6	After drying, the primary standard shall be used within 8 days from the date of
	drying.
3.5.7	At the time of drying the weighing bottle shall be labeled with the name of
	primary standard by marker pen. After drying is over it shall be labeled with
	details as per annexure-7.

4.0	DOCUMENTATION :
4.1	Codes of various volumetric solutions - Annexure 1.
4.2	Specimen format of "Record of Analysis" volumetric solutions - Annexure  2.
4.3	Specimen format of "Record of Analysis - pH Buffer solutions"  - Annexure 3.
4.4	Specimen format of "Lables of pH buffer solutions, Test solutions, HPLC mobile phases"
	- Annexure 4.
4.5	Specimen format of label for "Volumetric solutions" - Annexure 5.
4.6	Specimen format of "Primary Standard Drying register " - Annexure 6.
4.7	Specimen format of "Primary Standard Label " - Annexure 7.

Users of this SOP are requested to prepare suitable annexures on their own.