Decree of the Ministry of Health No. 296 / 1999 Coll.
Decree of the Ministry of Health amending Decree of the Ministry of Health No. 1 / 1998 Coll., laying down requirements for quality, procedure for preparation, testing, storage and dosing of medicines (Czech Pharmacopoeia 1997)
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Effective from 01.01.2000
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01.01.2000
20.12.1999
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296
DECLARATION
Ministry of Health
of 19 November 1999
amending Decree No. 1 / 1998 of the Ministry of Health Coll., laying down quality requirements, procedure for the preparation, testing, storage and dosing of medicinal products (Czech Pharmacopoeia 1997)
The Ministry of Health, after consulting the Ministry of Agriculture and the Ministry of Industry and Trade, provides, pursuant to § 75 (4) of Act No. 79 / 1997 Coll., on Medicines and on amendments and additions to certain related laws:
The amendments to the Czech Pharmacopoeia 1997 published in the Annex to Decree No. 1 / 1998 of the Ministry of Health Coll. are contained in the Annex to this Decree.
This decree shall take effect on 1 January 2000.
Minister:
Dr. David, CSc.
Annex to Decree No. 296 / 1999 Coll.
_
-
ADDITIONAL 1999
Amendments to the Czech Pharmacopoeia 1997
The following amendments shall be made to the Annex to Decree No 1 / 1998 of 9 December 1997 laying down the quality requirements, the procedure for the preparation, testing, storage and dosing of medicinal products (1):
1) The changes marked (E) are taken from Ph. Eur. 3 - Supply. 1999
| str. 13 (E) | Značky a symboly |
10th to 4th row from bottom:
| nový text: | C.I.P. | Collection de Bactéries de l’Institut Pasteur |
| B.P. 52, 25 Rue du Docteur Roux | ||
| 75724 Paris Cedex 15, France | ||
| I.P. | Collection Nationale de Culture de Microorganismes (C.N.C.M.) | |
| Institut Pasteur, | ||
| 25 Rue du Docteur Roux | ||
| 75724 Paris Cedex 15, France |
| str. 32 | Fyzikální a fyzikálně-chemické metody |
Paragraph Red solution:
Line 5:
Current text:... hydrogen peroxide diluted R...
new text:... hydrogen peroxide diluted with RS...
6.
current text:... sulphuric acid diluted R...
new text:... sulphuric acid diluted with RS...
Paragraph Blue solution:
Line 5:
current text:... acetic acid diluted R...
new text:... acetic acid diluted with RS...
p. 38
1st line from bottom:
current text: * * Use bromotymol blue solution R1
new text: * * Use blue bromothymol RS1
p. 64 (E)
Paragraph Number of theoretical floors, 1st row:
current text:... isothermic conditions...
new text:... isocratic conditions...
| str. 84 | Zkoušky totožnosti |
The title of the paragraph Ammonium salts is replaced by the title Ammonium salts
The title of the paragraph Ammonium salts and volatile base salts is replaced by the title Ammonium salts and volatile base salts
p. 85
Paragraph Bromida, (b), third row:
current text:... acetic acid R...
new text:... acetic acid RS...
p. 88
row 3:
current text:... ammonia 26% RS...
new text:... ammonia 26% R...
Paragraph Lead, (a) and (b), first row:
current text:... acetic acid R...
new text:... acetic acid RS...
Paragraph Salicylany, (a), second row:
current text:... acetic acid R...
new text:... acetic acid RS...
p. 89
Paragraph Calcium, (b) 1st row:
current text:... acetic acid R...
new text:... acetic acid RS...
| str. 96 | Limitní zkoušky |
Paragraph 2.4.8 Heavy metals, Method A, 4th row:
Current text:... 2 ml of test solution...
new text:... 2 ml of prescribed aqueous solution...
p. 97
row 1:
Current text:... 2 ml of test solution...
new text:... 2 ml of prescribed aqueous solution...
Paragraph Method B:
6.
Current text:... 2 ml of test solution...
new text:... 2 ml of prescribed aqueous solution...
8 to 9 rows:
Current text:... 2 ml of test solution...
new text:... 2 ml of prescribed aqueous solution...
Paragraph Method C:
6th line from bottom:
Current text:... 2 ml of test solution...
new text:... 2 ml of solution obtained from the test substance...
4th line from bottom:
Current text:... 2 ml of test solution...
new text:... 2 ml of solution obtained from the test substance...
p. 98
Paragraph Method D:
6th line from bottom:
Current text:... 2 ml of test solution...
new text:... 2 ml of solution obtained from the test substance...
4th line from bottom:
Current text:... 2 ml of test solution...
new text:... 2 ml of solution obtained from the test substance...
p. 100
Paragraph 2.4.13 Sulphates, 4th row:
current text:... acetic acid R...
new text:... acetic acid RS...
p. 110
5 and 6 rows:
current text: - hydrogen for chromatography R as carrier gas at a flow rate of 30 cm / min to 50 cm / min or helium for chromatography R at a flow rate of 20 cm / min to 35 cm / s...
new text: - hydrogen for chromatography R as carrier gas at a flow rate of 30 cm / s to 50 cm / s or helium for chromatography of R at a flow rate of 20 cm / s to 35 cm / s...
| str. 114 | 2.4.25 Zbytkový ethylenoxid a dioxan |
Paragraph B, line 11:
current text:... and 0,10 ml of RS1 dioxane...
new text:... and 0,10 ml of RS dioxane...
p. 114 (E)
Paragraph B, 12th row:
Current text:... homogeneous solution.
new text:... homogeneous solution and leave to stand 45 min at 70 ° C.
| str. 118 | Stanovení obsahu |
3rd row under Tab. 2.5.4-1:
current text:... iodine R bromide...
new text:... iodine RS bromide...
p. 119
4th line from bottom:
current text:... phenolfialein R...
new text:... phenolfialein RS...
p. 121
Paragraph Calcium, row 2:
current text:... calconocarboxylic acid with sodium chloride R...
new text:... calconcarboxylic acid with sodium chloride R...
| str. 155 | Biologické zkoušky |
Paragraph Silent solution with sodium chloride and peptone pH 7,0, 1., 2. and 3.
5), including heel note: 5) corresponds to 0,067 mol / l.
| str. 198 (E) | 2.7.4 Stanovení účinnosti krevního koagulačního faktoru VIII |
Paragraph Survey, 14, 15 and 16:
current text:... The final concentration of phospholipid during factor Xa formation is 1 nmol / l to 50 nmol / l, preferably 10 nmol / l to 35 nmol / l. The probe contains calcium ions at a final concentration of 5 nmol / l to 15 mmol / l....
new text:... The final concentration of phospholipid during factor Xa formation is 1 μmol / l to 50 μmol / l, preferably 10 μmol / l to 35 μmol / l. The probe contains calcium ions at a final concentration of 5 mmol / I to 15 mmol / l....
| str. 216 | Farmakognostické metody |
Tab. N-1, column Required oil content in ml / kg, 3rd row:
Current text: ≥ 10.0
New text: > 10,0
p. 329
Paragraph Residue after evaporation, row 2:
current text:... maximum 0,2 mg...
new text:... not more than 2,0 mg...
| str. 614 (E) | Statistické analýzy výsledků biologických zkoušek |
Tab. 3.2.8.1-VI Distraction analysis excluding Z data, column P, 2nd row:
current text: > 0,05
New text: < 0,05
| str. 762 | Doporučené dávky některých oficinálních |
Paragraph PROCAINI HYDROCHLORIDUM, line 5:
Current text:... C, F: 2% solution up to 20 ml (0,2 g)
new text:... C, F: 1% solution up to 20 ml (0,2 g)
p. 767
Paragraph TRIAMCINOLONI ACETONIDUM:
4th row:
current text: F: 0,11-022 mg.kg-1...
new text: F: 0,11-0,22 mg.kg-1...
6.
current text: intraarthritis....
new text: intraartic....
| str. 786 (E) | Aciclovirum |
row 4 and 5:
current text:... at least 7 (calculated V0 from the peak corresponding to acetic acid)....
new text:... at least 7 (V0is calculated using dimethylsulfoxide R)....
| str. 788 | Acidum aceticum 99% |
Paragraph Reducing substances, row 2 and row 3:
Current text:... potassium dichromate 0,167 mol / l VS...
new text:... potassium dichromate 0,0167 mol / l VS...
| str. 813 | Acidum hydrochloricum 35% |
Paragraph Free chlorine, row 3:
current text:... (4 μg / ml).
new text:... (4 μg / g).
Paragraph Sulphates, row 3:
current text:... (20 μg / ml).
new text:... (20 μg / g).
Paragraph Arsen, row 2:
current text:... (2 μg / ml).
new text:... (2 μg / g).
Paragraph Heavy metals, row 3:
current text:... (2 μg / ml).
new text:... (2 μg / g).
| str. 814 | Acidum hydrochloricum 10% |
Paragraph Free chlorine, row 3:
current text:... (1 μg / ml).
new text:... (1 μg / g).
Paragraph Sulphates, row 3:
current text:... (5 μg / ml).
new text:... (5 μg / g).
Paragraph Arsen, row 2:
current text:... (0,5 μg / ml).
new text:... (0,5 μg / g).
| str. 836 | Acidum salicylicum |
Paragraph Solution appearance, line 1:
current text: 1,0 g is dissolved in 96% R....
new text: 1,0 g dissolve in 10 ml alcohol 96% R....
p. 837
Paragraph Sulphates, line 5 and 6:
current text:... calcium chloride R...
new text:... chloride of bamboo R...
| str. 843 | Acidum tiaprofenicum |
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Regulation Information
| Citation | Decree of the Ministry of Health No. 296 / 1999 Coll., amending Decree of the Ministry of Health No. 1 / 1998 Coll., laying down requirements on quality, procedure for preparation, testing, storage and dosing of medicines (Czech Pharmacopoeia 1997) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.12.1999 |
|---|---|
| Effective from | 01.01.2000 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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