MOD 6: QC/QA - 3

Proverbs 16:3

I

Apparatus No: Basket (100 rpm)

II

Apparatus No: Paddle (50 rpm)

III

Apparatus No: Reciprocating Cylinder

IV

Apparatus No: Flow Through Cell

V

Apparatus No: Paddle Over Disk

VI

Apparatus No: Rotating Cylinder

VII

Apparatus No: Reciprocating Holder

Apparatus No. V, VI, VII

Dissolution Apparatuses for TDDS (3)

NLT 90%

Passing Criteria for Samples of < 60 g or 60 mL in Minimum Fill Test

NLT 95%

Passing Criteria for Samples of > 60 g or mL but NMT 150 g or mL in Minimum Fill Test

Stage 1 = 3 Rabbits; Stage 2 (Retest) = 5 Rabbits; Total = 8 Rabbits

Number of Rabbits used in Pyrogen Test

> 0.5 deg C

Criteria for Pyrogen Test Stage 1: No Rabbit should have an individual Temperature rise of > _____ deg C

3.3 deg C

Criteria for Pyrogen Test Stage 2: NMT 3 Rabbits should have an individual Temperature rise of > 0.5 deg C, and the TOTAL temperature rise for 8 rabbits should be less than or equal to ___ deg C

Glass Grains Test

Test for hydrolytic resistance of glasses; distinguishes Type I from II and III

Surface Glass Test

Test for hydrolytic resistance of inner surface of glasses; dinstinguishes Type I and II from III

Surface Etching Test

Glass test that determines if the hydrolyic resistsance is due to treatment (Type II) or glass composition (Type I)

Powedered Glass Test

Test for Type I and III glass

Water Attack Test

Test for Type II glass

Bubble point

Test for membrane filter integrity

Dioctylphthalate Test (DOP test)

Test for HEPA Filter integrity

25 ± 2 deg C; 60 ± 5% RH

Storage Conditions for Long-Term Stability Studies (12 months)

40 ± 2 deg C; 75 ± 5% RH

Storage Conditions for Accelerated Stability Studies (12 months)

30 ± 2 deg C; 65 ± 5% RH

Storage Conditions for Alternate Stability Studies (12 months)

180-380 nm

Wavelength of UV region in nm

380-780 nm

Wavelength of Visible Light region in nm

780-3000 nm

Wavelength of Near IR region in nm

3-15 um

Wavelength of Medium IR region in um

15-30 um

Wavelength of Far IR region in nm