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GIBRALTAR LABORATORIES
CHEMISTRY TEST SERVICES

 
SERVICE

TURN AROUND TIME

SAMPLE QUANTITY
_______________________________________________________________________

1.         

1,4-DIOXANE

Varies

Varies

2.         

ACCELERATED AGING

 

 

3.         

ACCELERATED AGING/STABILITY TESTING

Varies

 

4.         

ACID VALUE

Varies

Varies

5.         

ACIDITY

Varies

Varies

6.         

ASTM C110 Standard Test Methods for Physical Testing of Quicklime, Hydrated Lime, and Limestone

Varies

Varies

7.         

ASTM D1193 Standard Specification for Reagent Water

Varies

Varies

8.         

ASTM D1209 Standard Test Method for Color of Clear Liquids (Platinum-Cobalt Scale)

Varies

Varies

9.         

ASTM D1293 Standard Test Methods for pH of Water

Varies

Varies

10.      

ASTM D153 Standard Test Methods for Specific Gravity of Pigments

Varies

Varies

11.      

ASTM D1544 Standard Test Method for Color of Transparent Liquids (Gardner Color Scale)

Varies

Varies

12.      

ASTM D565 Standard Test Method for Carbonizable Substances in White Mineral Oil

Varies

Varies

13.      

ASTM D891 Standard Test Methods for Specific Gravity, Apparent, of Liquid Industrial Chemicals

Varies

Varies

14.      

ASTM D914 Standard Test Methods for Ethylcellulose

Varies

Varies

15.      

ASTM E313 Standard Practice for Calculating Yellowness and Whiteness Indices from Instrumentally Measured Color Coordinates

Varies

Varies

16.      

ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Varies

Varies

17.      

ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

Varies

Varies

18.      

AVOBENZONE ASSAY

Varies

Varies

19.      

BENZOCAINE ASSAY

14 Days

1 Unit

20.      

BRITISH PHARMACOPEIA PURIFIED WATER (TOC, CONDUCTIVITY, NITRATES, HEAVY METALS)

 7 Days

 

21.      

BUTYLMETHOXYDIBENZOMETHANE

 

 

22.      

CAFFEINE ASSAY

Varies

Varies

23.      

CALORIES

1 Day

 

24.      

CARBOHYDRATE (TOTAL)

 

 

25.      

CARBON DIOXIDE

 

 

26.      

CHLORIDE

 

 

27.      

CHROMATOGRAPHIC PURITY

Varies

Varies

28.      

CLEANING VALIDATION

Varies

Varies

29.      

COLOR

 1 Day

 

30.      

CONDUCTIVITY

1 Day

 

31.      

CONSULTATION

Varies

 Varies

32.      

DEXASAMETHASONE ACETATE ASSAY

14 Days

1 Unit

33.      

DIMETHICONE ASSAY

Varies

Varies

34.      

DIOXANE-1,4

Varies

Varies

35.      

DISPERSABILITY IN WATER

7 Days

 

36.      

DISSOLUTION

14 Days

Varies

37.      

DRAEGER DIRECTIONAL

Varies

Varies

38.      

ELASTIN ASSAY (SOLUBLE INSOLUBLE AND TOTAL ELASTINS)

1 Week

Varies

39.      

ELEMENTAL ANALYSIS (C, N, H, O, S)

Varies

Varies

40.      

EPA RED GLP PRODUCT CHEMISTRY

Varies

Varies

41.      

EPA SUBDIVISION D:PRODUCT CHEMISTRY

3-4 Weeks

Varies

42.      

ETHYLENE OXIDE RESIDUAL ANALYSIS

21 Days

 

43.      

EUROPEAN PHARMACOPEIA PURIFIED WATER TOC <2.2.44> CONDUCTIVITY

 

40 mL/100 mL

44.      

EUROPEAN PHARMACOPOEIA WET CHEMISTRY TESTS

 2 Days

 

45.      

EXPIRATION DATING

 

 

46.      

EXPIRATION DATING

 

 

47.      

FAT (SATURATED)

 

 

48.      

FAT (TOTAL)

 

 

49.      

FIBER (TOTAL DIETARY)

 

 

50.      

FIBER (TOTAL SOLUBLE)

 

 

51.      

FLOURIDE ANALYSIS BY ION SELECTIVE ELECTRODES [TOTAL, AVAILABLE AND FREE FLOURIDE]

Varies

Varies

52.      

FOOD CHEMISTRY

 21 Days

 

53.      

FORMALDEHYDE

Varies

Varies

54.      

FTIR ANALYSIS

 7 Days

 

55.      

GC CHEMISTRY

 21 Days

 

56.      

GLUTARALDEHYDE

Varies

Varies

57.      

HPLC CHEMISTRY POTENCY/IDENTITY

 

 

58.      

ICH STORAGE

 Varies

 

59.      

INSULIN CONTENT

 

 

60.      

INTERFERON ASSAY

14 Days

Varies

61.      

IODINE VALUE

Varies

Varies

62.      

ISO 4730 TEA TREE OIL

Varies

Varies

63.      

ISO 8871-1: 2003 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE -- PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE -- PART 2: IDENTIFICATION AND CHARACTERIZATION

 

 

64.      

ISO 8871-1-4 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE

Varies

Varies

65.      

JAPANESE PHARMACOPEIA PURIFIED WATER

 5 Days

 

66.      

KARL FISHER

 1 Day

 

67.      

LIDOCAINE ASSAY

Varies

Varies

68.      

LINALOOL ASSAY

Varies

Varies

69.      

LOSS ON DRYING

 1 Day

 

70.      

MELTING RANGE

1 Day

 

71.      

MENTHOL ASSAY

14 Days

1 Unit

72.      

METHOD DEVELOPMENT

Varies

Varies

73.      

METHOD TRANSFER

Varies

Varies

74.      

METHOD VALIDATION

Varies

Varies

75.      

NALTREXONE

 7-14 Days

 

76.      

NITROGEN

 14-21 Days

 

77.      

NITROGEN MONOGRAPH (PURITY)

 21 Days

 

78.      

NON-VIABLE PARTICULATE COUNT (GAS)

 1 Day

 

79.      

OCTYLMETHOXYCINNAMATE

 7-14 Days

 

80.      

OCTYLMETHOXYDIBENZOMETHANE

 7-14 Days

 

81.      

ORDINARY IMPURITIES

Varies

Varies

82.      

OXYBENZINE

 7-14 Days

 

83.      

PADIMATE o [2-THYLHEXYLPARA(DIMETHYLAMINO) BENZOATE)

 

 

84.      

PARABEN ANALYSIS

 

 

85.      

PARTICLULTE SIZING <788>

 14 Days

 

86.      

PERCENT MOISTURE BY GRAVIMETRIC METHOD

 4 Days

 

87.      

pH USP <791>

1 Day

30mL

88.      

PROCESS VALIDATION

Varies

Varies

89.      

PROTEIN

 

 

90.      

PURE STEAM CONDENSATE

1 Day

100-200 mL

91.      

QUATERNARY AMMONIUM ASSAY

 1 Day

 

92.      

RESIDUE ON IGNITION

 1 Day

 

93.      

RUSH/STAT CHARGE

 Varies

Varies

94.      

SEEDED INJECTION VALIDATION

 7 Days

 

95.      

SHAKER FLASK TEST

48 Hours

 

96.      

SIEVE ANALYSIS

Varies

Varies

97.      

SILVER NITRATE

Varies

Varies

98.      

SOP PREPARATION

 Varies

N/A

99.      

SPECIFIC GRAVITY

 

 

100.   

SPORE STRIP STERILITY TEST

7 Days

Varies

101.   

SUGARS (FOS, D-FRUCTOSE, D-GLUCOSE)

 

 

102.   

TEA TREE OIL ASSAY BY ISO 4730

 

 

103.   

TITANIUM DIOXIDE

7-14 Days

Varies

104.   

TITANIUM DIOXIDE ASSAY

 7-14 Days

 

105.   

TITRATION

Varies

Varies

106.   

TOTAL ORGANIC CARBON (TOC) <643>

 7 Days

 

107.   

UPSTREAM QATM

 

Advance Scheduling, Acknowledgement and Paper Audit of Test samples

108.   

USP <1125> VALIDATION OF COMPENDIAL METHODS

Varies

Varies

109.   

USP <206> ALUMINUM

Varies

Varies

110.   

USP <211> ARSENIC, METHOD I AND II

Varies

Varies

111.   

USP <231> HEAVY METALS

 Varies

Varies

112.   

USP <231> HEAVY METALS, METHOD I, II AND III

Varies

Varies

113.   

USP <241> IRON

Varies

Varies

114.   

USP <251> LEAD

Varies

Varies

115.   

USP <271> READILY CARBONIZABLE SUBSTANCES

Varies

Varies

116.   

USP <401> HYDROXYL VALUE

Varies

Varies

117.   

USP <401> PEROXIDE VALUE

Varies

Varies

118.   

USP <401> SAPONIFICATION VALUE

Varies

Varies

119.   

USP <45> CONDUCTIVITY

 

100 mL

120.   

USP <467> ORGANIC VOLATILE IMPURITIES

Varies

Varies

121.   

USP <467> RESIDUAL SOLVENTS

Varies

Varies

122.   

USP <565> BOTANICAL EXTRACTS

Varies

Varies

123.   

USP <643> TOTAL ORGANIC CARBON (TOC)

 7 Days

 

124.   

USP <645>WATER CONDUCTIVITY

Varies

Varies

125.   

USP <651> CONGEALING RANGE

Varies

Varies

126.   

USP <651> CONGEALING TEMPERATURE

Varies

Varies

127.   

USP <661> PHYSICOCHEMISTRY TESTING

 

 

128.   

USP <671> CONTAINERS PERMEATION

14 Days

20-50 Units

129.   

USP <711> DISSOLUTION

14 Days

Varies

130.   

USP <741> MELTING RANGE

Varies

Varies

131.   

USP <755> MINIMUM FILL

Varies

Varies

132.   

USP <788> PARTICULATE ANALYSIS

 14 Days

 

133.   

USP DIMETHICONE

Varies

10 grams

134.   

UV/VIS (assay)

Varies

Varies

135.   

VISCOSITY

 

 

136.   

WATER VALIDATION

Varies

Varies

137.   

WATER-INSOLUBLE SUBSTANCES

Varies

Varies

138.   

WET CHEMISTRY

 7 Days

 

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