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Specification Enclosure 01 to PS-EP-001 ed. 02, doc. no. 500002 Page 1 of 1 Alhydrogel ® 2% Aluminium Hydroxide Gel Adjuvant, Al: 10 mg/mL Tested for Ph.Eur. compliance Test Parameter Acceptable Range Aluminium (Al) 9.0 mg/mL – 11.0 mg/mL pH (at the time of production) 5.5 – 8.5 Adsorption Power No detectable BSA in solution Sedimentation ≤ 5 mL supernatant Chloride (Cl) ≤ 0.33% w/w Nitrate (NO 3 ) ≤ 100 ppm Sulphate (SO 4 ) ≤ 0.5% w/w Ammonium (NH 4 ) ≤ 50 ppm Arsenic (As) ≤ 1 ppm Iron (Fe) ≤ 15 ppm Heavy Metals ≤ 20 ppm pH (at the time of production) 6.0 – 7.0 Pyrogenicity in 3 rabbits* ≤ 1.15°C (Pyrogenicity in 6 rabbits* ≤ 2.80°C) Sterility No growth in test samples *: The bacterial endotoxin test 2.6.14 prescribed in EP monograph 1664 is problematic with Alhydrogel, since the phosphate residues of LPS (used as positive control and standard curve) bind unspecifically to Alhydrogel. This opinion is shared by the Danish Medicines Agency. We carry out the pyrogenicity test on the liquid phase of the product according to the EP 2.6.8 instead of the bacterial endotoxin test. Shelf life: 26 months after production date. Store at room temperature. Protect from freezing. Shake well before use. Reference: European Pharmacopoeia, monograph 1664, current edition Brenntag Biosector guarantees the specifications above under the liability specified in the company’s ”General Conditions of Sale and Delivery”. However, individual customers may have internal specifications and/or acceptance limits or specifications which may include additional quality parameters reflecting their particular application of the product. Brenntag Biosector does not accept to be held liable for any such additional parameter, nor guarantees any compliance with such, unless previously explicitly agreed in writing between the parties. It is the sole responsibility of the customer to test the product for any such parameter that goes beyond the standard specifications of Brenntag Biosector before adding the adjuvant to their vaccine.

Specification Alhydrogel 2% - · PDF fileAluminium (Al) 9.0 mg/mL – 11.0 mg/mL pH (at the time of production) ... of the product according to the EP 2.6.8 instead of the bacterial

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Page 1: Specification Alhydrogel 2% - · PDF fileAluminium (Al) 9.0 mg/mL – 11.0 mg/mL pH (at the time of production) ... of the product according to the EP 2.6.8 instead of the bacterial

Specification

Enclosure 01 to PS-EP-001 ed. 02, doc. no. 500002 Page 1 of 1

Alhydrogel® 2% Aluminium Hydroxide Gel Adjuvant, Al: 10 mg/mL

Tested for Ph.Eur. compliance

Test Parameter Acceptable Range

Aluminium (Al) 9.0 mg/mL – 11.0 mg/mL

pH (at the time of production) 5.5 – 8.5

Adsorption Power No detectable BSA in solution

Sedimentation ≤ 5 mL supernatant

Chloride (Cl) ≤ 0.33% w/w

Nitrate (NO3) ≤ 100 ppm

Sulphate (SO4) ≤ 0.5% w/w

Ammonium (NH4) ≤ 50 ppm

Arsenic (As) ≤ 1 ppm

Iron (Fe) ≤ 15 ppm

Heavy Metals ≤ 20 ppm

pH (at the time of production) 6.0 – 7.0

Pyrogenicity in 3 rabbits* ≤ 1.15°C

(Pyrogenicity in 6 rabbits* ≤ 2.80°C)

Sterility No growth in test samples

*: The bacterial endotoxin test 2.6.14 prescribed in EP monograph 1664 is problematic with A lhydrogel, since

the phosphate residues of LPS (used as positive control and standard curve) bind unspecifically to Alhydrogel.

This opinion is shared by the Danish Medicines Agency. We carry out the pyrogenicity test on the liquid phase

of the product according to the EP 2.6.8 instead of the bacterial endotoxin test.

Shelf life: 26 months after production date.

Store at room temperature. Protect from freezing. Shake well before use.

Reference: European Pharmacopoeia, monograph 1664, current edition Brenntag Biosector guarantees the specificat ions above under the liab ility specified in the company’s ”General

Conditions of Sale and Delivery”. However, individual customers may have internal specificat ions and/or

acceptance limits or specifications which may include additional quality parameters reflecting their particular

application of the product.

Brenntag Biosector does not accept to be held liable for any such additional parameter, nor guarantees any

compliance with such, unless previously explicitly agreed in writ ing between the parties.

It is the sole responsibility of the customer to test the product for any such parameter that goes beyond the

standard specifications of Brenntag Biosector before adding the adjuvant to their vaccine.

0.96 mg/ml

0.96 mg/ml

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