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Theory intoPractice
David Clarke BSc (Hons), MSc
Physics
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Stability Testing: Theoryinto Practice• Reglations overvie!
• "b#ectives o$ Stability Testing
• Testing Protocols
•%nter&retation o$ reslts
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Reglations "vervie!•
Cos'etic Prodct 'st be sa$e $or h'an health• Proven by Cos'etic Prodct Sa$ety Re&ort (CPSR)
• Re&ort inclded in P%
• Part * Cos'etic Prodct Sa$ety %n$or'ation
• +antitative -alitative co'&osition
•
Physical.che'ical characteristics &rodct stability• Microbiological -ality
• %'&rities, traces, &ackaging in$or'ation &ackagingstability
• /or'al.$oreseeable se
• Prodct.sbstance e0&osre
• To0icological &ro1le
• 2ndesirable.seriosly ndesirable e3ects
• "ther in$or'ation
• Part B * Cos'etic Prodct Sa$ety ssess'ent
• Conclsions $ro' Part
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Reglations "vervie!
• 4abelling
• Date o$ Mini'' Drability
• %$ Date o$ Mini'' Drability e0ceeds 56
'onths• P"
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Reglations "vervie!
• 7age re-ire'ents
• Testing condcted shold be s&eci1c to the&rodct and the ty&e o$ data re-ired $ro' it8
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"b#ectives o$ Stability Testing
• De1nition * 9Deter'ine !hether a particularformulation, in its immediate packagingcan retain its intended physical & chemicalstability and microbiological quality,
inclding its intended function andaesthetics nder the conditions of themarket in !hich it is to be sold8
• 2nderstand ho! the &rodct shall $air over
ti'e• Pri'ary concern * sa$ety
• Secondary concern * Brand . Man$actrerre&tation
• t !hat &oint are changes nacce&table;
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"b#ectives o$ Stability Testing
• Prodct Stability * Prodct stored and tested
in inert, i'&er'eable glass #ars
• Container Co'&atibility * Prodct and the
1nal, i''ediate &ackaging tested together
• Reco''end condcting both stability and
co'&atibility• Deter'ines &rodct or &ackaging instability
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Ty&es o$ Stability Tests
• Real Ti'e Stability Testing
• Stored in actal 'arket conditions $or the
dration o$ 'ini'' drability
•
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Ty&es o$ Stability Tests
• ccelerated Stability Testing
• Stored nder varios conditions to accelerate
changes occrring nder nor'al conditions *
&redicts stability
• Bene1ts * data ac-ired relatively -ickly
• Disadvantages *
• %nstabilities in real ti'e testing 'ay not occr in
accelerated testing
• Harsher conditions 'ay reslt in degradation that
!old never occr nder nor'al conditions
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Te'&eratre
• n increase o$ ?6@C $ro' a'bient
te'&eratre dobles the rate o$ reaction
• 'bient > A6@C
• 6@C stored $or 5 'onths
•
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Te'&eratre
• lternate rti1cial ging ides
• ?A !eeks at @C e-ates to A 'onths
• ?A !eeks at @C e-ates to 56 'onths
• ?E !eeks at @C e-ates to 56 'onths
• ides deter'ined by the Brand .Man$actrer * Fhat do yo think is
acce&table;• Fhere is the intended 'arket;
•
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Te'&eratre
• Sa'&les stored at chilled te'&eratre *Control
• 2sed $or co'&arisons
• So'e sa'&les stored as close to the a'bient'arket conditions
• ssess roo' te'&eratre stability
• Store in dark conditions
• Storage conditions 'st be controlled
• Te'& control range, Gctations variations
• Storage te'&eratre 'onitored daily
• Calibrate 'onitoring e-i&'ent reglarly
• 68@C, ?86@C %ncbator . $ridge constraints;
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Relative H'idity
• %''ediate &ackaging test (co'&atibility)
• Does the &ack &rovide ade-ate &rotection;
• chieved sing satrated salt soltions in a sealedcha'ber
• Control at a'bient
• Test at h'id dry conditions
• Monitor daily
• Calibrate 'onitoring e-i&'ent
Satrated
Soltion
Te'&eratre @C
?6 A6 56 6
I/"5 J J5 J? KK
/aC4 LE LE L LI AC"5 L 5 A
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Cycling . reee Tha! Tests
• lctating conditions at reglar intervals canbe 'ore stress$l than constant conditions
• Cycling
• 'bient N 6@C N 'bient over A hors
• reee Tha!
• >?6@C N 6@C N >?6@C over A hors
• A !eek test ti'e
• Consider trans&ort . storage conditions
• 4ikely to be 'ore severe than yo antici&ated
• Set te'&eratre controller to cycle bet!eente'&eratres
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4ight
• Photostability o$ &rodct and i''ediate&ackaging
• Findo! light 'ethod• /atral daylight * /orth $acing
• Mini'ise direct snlight
• Co'&are to controlled sa'&les ke&t in darkcondition
• Dark incbator
• "RO Fra&&ed in al'ini' $oil
• Consider season and !eather variations as ite3ects the intensity o$ light
•
/ot a controlled 'ethod
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4ight
• ccelerated light 'ethod
• 4ight cabinet * SnTest CPS
• 4a'& covers !hole or broad s&ectr' o$ light
• e8g8 Qenon la'&
• 7arios 1lters available * 27
• 2tilise cooling syste' * re'ove e3ects cased
by te'&eratre
• Record data * radiant e0&osre, te'&eratre
and ti'e
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4ight•
Control sa'&le !ra&&ed in al'ini' $oil
• Test sa'&le e0&osed to light
• Test &rotocols
•
6F.'A
!ith C grade 1lter (!indo!), A 0 ?6 hore0&osre (A tests)
• 6F.'A !ith C grade 1lter (!indo!), 5 hor to
'a0i'' ?A hor e0&osre (&otentially tests)
• 6F.'A !ith C grade 1lter (!indo!), L 0 ?6 hor
e0&osre (L tests)
• 6F.'A !ith C grade 1lter (!indo!), A6 hor
e0&osre (? test)
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Test Points•
%nitial readings•
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7ol'e . Pack /'berRe-ire'ents• De&endant on
• /'ber o$ test conditions
• /'ber o$ test &oints
• Tests re-ired
• Prodct ty&e
• Make 'ore than yo think yo need
• Retest the sa'e sa'&le . &ack throghottest;
• Si'lates cons'er sage
• "RO test ne! sa'&le . &ack at each test∮
• Si'lates &rodct o&ened $or the 1rst ti'e
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%nter&retation
• Prodct s&eci1cations• otside o$ s&eci1cation * nsatis$actory *
re$or'late . ne! &ack
• Fere the s&eci1cations too narro!;
• ccelerated test• changes observed an accrate &rediction o$
arti1cial ageing;
• "RO changes de to conditions being too $ar
re'oved $ro' the reasonably $oreseeableconditions;
• Does the &rodct retain its initial $nction andre'ain sa$e;
• re the changes aesthetic;