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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Dapoxetine Impurity 3 Dapoxetine Impurity 3
Regorafenib Impurity 16 Regorafenib Impurity 16
Topiroxostat Impurity 7 Topiroxostat Impurity 7
Tofacitinib Impurity 12 Tofacitinib Impurity 12
Ticagrelor Impurity 16 Ticagrelor Impurity 16
Ticagrelor Impurity 22 Ticagrelor Impurity 22
Milrinone Impurity 5 Milrinone Impurity 5
Caspofungin Impurity 4 Caspofungin Impurity 4 258510-40-6 C49H78N8O17
Canagliflozin Impurity 27 Canagliflozin Impurity 27
Loxoprofen Impurity 1 Loxoprofen Impurity 1
Febuxostat Impurity 54 Febuxostat Impurity 54
Atropine Impurity 4 Atropine Impurity 4 3423-23-2 C17H23NO3
Silodosin Impurity B Silodosin Impurity B
Cefminox Sodium impurity F Cefminox Sodium impurity F
Clindamycin Impurity F Clindamycin Impurity F
Fasudil iMpurity D Fasudil iMpurity D
2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 929540-41-0 C36H41CaFN2O5
Doxofylline iMpurity C Doxofylline iMpurity C
Puerarin-4'-O-β-D-glucopyranoside Puerarin-4'-O-β-D-glucopyranoside 117047-08-2 C27H30O14
N-Propyl-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one N-Propyl-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one 2512208-76-1 C15H21NO3
3-Pyrazolidinone, 5-cyclopentyl-, (5R)-, (2S,3S)-2,3-dihydroxybutanedioate (1:1) 3-Pyrazolidinone, 5-cyclopentyl-, (5R)-, (2S,3S)-2,3-dihydroxybutanedioate (1:1) 2102675-37-4 C12H20N2O7
1(2H)-Naphthalenone, 4-hydroxy-3-methyl-2-[(2E,6E,10E)-3,7,11,15-tetramethyl-2,6,10,14-hexadecatetraen-1-ylidene]- 1(2H)-Naphthalenone, 4-hydroxy-3-methyl-2-[(2E,6E,10E)-3,7,11,15-tetramethyl-2,6,10,14-hexadecatetraen-1-ylidene]- 693781-59-8 C31H40O2
Bisoprolol Impurity 50 Bisoprolol Impurity 50
Milnacipran Impurity 26 Milnacipran Impurity 26
Olodaterol Impurity 15 Olodaterol Impurity 15
	Olodaterol Impurity 32 Olodaterol Impurity 32
(R)-Lercanidipine Hydrochloride (R)-Lercanidipine Hydrochloride 187731-34-6 C36H42ClN3O6
2-Oxo Clopidogrel Hydrochloride(Mixture of diastereomers) 2-Oxo Clopidogrel Hydrochloride (Mixture of diastereomers) 109904-27-0 C16H16ClNO3S
5-Hydroxy-6-methoxy-1-indanone 5-Hydroxy-6-methoxy-1-indanone 127399-78-4 C10H10O3
Desfluoro Citalopram Oxalate Desfluoro Citalopram Oxalate 1093072-86-6 C22H24N2O5
Didesmethyl Zolmitriptan Didesmethyl Zolmitriptan 139264-15-6 C14H17N3O2
Gabapentin Related Compound E Gabapentin Related Compound E 67950-95-2 C9H14O4
Hydroxy Bosentan Hydroxy Bosentan 253688-60-7 C27H29N5O7S
Lisinopril S,S,S-Diketopiperazine Lisinopril S,S,S-Diketopiperazine 328385-86-0 C21H29N3O4
rac 4-Desmethoxy-4-nitro Omeprazole rac 4-Desmethoxy-4-nitro Omeprazole 317807-10-6 C16H16N4O4S
trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol 201855-60-9 C19H22FNO
ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE 70458-94-5 C14H13ClFNO3
L-Proline, 5-oxo-, compd. with chitosan L-Proline, 5-oxo-, compd. with chitosan 117522-93-7
Dotinurad Impurity 22 Dotinurad Impurity 22 2142685-21-8 C15H14N2S2
Alvatrombopag Impurity 84 Alvatrombopag Impurity 84
Avatrombopag Impurity 60 Avatrombopag Impurity 60
2-Amino-4-(3-chlorothien-2-yl)-1,3-thiazole 2-Amino-4-(3-chlorothien-2-yl)-1,3-thiazole 339114-12-4 C7H5ClN2S2
Capecitabine Related Compound B Capecitabine Related Compound B
D-erythro-3,4-Dihydroxyphenylserine D-erythro-3,4-Dihydroxyphenylserine 51829-98-2 C9H11NO5
aztreonam aztreonam 80951-91-3 C13H17N5O8S2
5H-[1]Benzopyrano[2,3-b]pyridine,7-ethyl-(9CI) 5H-[1]Benzopyrano[2,3-b]pyridine,7-ethyl-(9CI) 639857-68-4 C14H13NO
[1,1-Biphenyl]-2,2,4,4,5,5-hexol(9CI) [1,1-Biphenyl]-2,2,4,4,5,5-hexol(9CI) 76625-61-1 C12H10O6
Esmolol Impurity 45 Esmolol Impurity 45
Oprinone Impurity 6 Oprinone Impurity 6
lamivudine sulfoxide lamivudine sulfoxide 160552-55-6 C8H11N3O4S
SRI 62320 SRI 62320 94061-80-0 C24H25FNNaO4
digoxigenin-mono(digitoxoside) digoxigenin-mono(digitoxoside) 5352-63-6 C29H44O8
W 36017 W 36017 21236-54-4 C12H18N2O
ONO EI-601 ONO EI-601 155023-59-9 C15H14N2O6S
2-[4-(2,3-EPOXYPROPOXY)PHENYL]ACETAMIDE 2-[4-(2,3-EPOXYPROPOXY)PHENYL]ACETAMIDE 29122-69-8 C11H13NO3
11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate 11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate 3044-42-6 C23H28O5
FEXOFENADINE EP IMPURITY A - HCl FEXOFENADINE EP IMPURITY A - HCl 153439-43-1 C32H38ClNO4
2-[(4-Chloro-3-Methyl-2-Pyridinyl-methyl)thio]-1H-Benzimidazole 2-[(4-Chloro-3-Methyl-2-Pyridinyl-methyl)thio]-1H-Benzimidazole 103312-62-5 C14H12ClN3S
Pazufloxacin Pazufloxacin 127046-18-8 C18H19FN2O4
Vinpocetine Vinpocetine 80038-06-8 C22H26N2O2
7-(but-2-yn-1-yl)-8-(3-(hydroxyimino)piperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione 7-(but-2-yn-1-yl)-8-(3-(hydroxyimino)piperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione 1297273-94-9
Isavuconazole Impurity 35 Isavuconazole Impurity 35
Brivaracetam Impurity 26 HCl Brivaracetam Impurity 26 HCl
Brivaracet amoxidation Impurity 1 Brivaracet amoxidation Impurity 1
Rosuvastatin EP Impurity G Complete Set Rosuvastatin EP Impurity G Complete Set
Bortezomib Impurity G Complete Set Bortezomib Impurity G Complete Set
Peramivir Diacetyl Impurity Peramivir Diacetyl Impurity
Peramivir Chlorisomeric Impurity Peramivir Chlorisomeric Impurity
Canagliflozin impurities 15 drops Canagliflozin impurities 15 drops
Pemetrexed Impurities 41-45 Pemetrexed Impurities 41-45
Pemetrexed Disodium EP Impurity 999 Pemetrexed Disodium EP Impurity 999
Bumetanide Impurity 999 Bumetanide Impurity 999
Canagliflozin Impurity 998 Canagliflozin Impurity 998
N,N-dimethyl-1,4,8,11-tetraazacyclotetradecane-1-sulfonamide N,N-dimethyl-1,4,8,11-tetraazacyclotetradecane-1-sulfonamide
Tamsulosin EP Impurity C (Desethoxy Tamsulosin) Tamsulosin EP Impurity C (Desethoxy Tamsulosin)
Itropopa Impurity 17 Itropopa Impurity 17
Cefazolin Epimer Cefazolin Impuirty M (USP), Cefazolin Impurity L (EP) Cefazolin Epimer Cefazolin Impuirty M (USP), Cefazolin Impurity L (EP)
Vitamin B12 e-Monocarboxylic Acid Vitamin B12 e-Monocarboxylic Acid 26264-28-8 C63H87CoN13O15P
caffeidine caffeidine 20041-90-1 C7H12N4O
metreleptin metreleptin 186018-45-1
3,5-DIIODO-4'-(4-HYDROXYPHENOXY)BENZOIC ACID 3,5-DIIODO-4'-(4-HYDROXYPHENOXY)BENZOIC ACID 2055-97-2 C13H6I4O4
Sotalol EP Impurity A Sotalol EP Impurity A 16974-42-8 C12H20N2O2S
norchlorpromazine norchlorpromazine 1225-64-5 C16H17ClN2S
ETHYLISOPROPYLNITROSAMINE ETHYLISOPROPYLNITROSAMINE 16339-04-1 C5H12N2O
1,3,5,7-Tetrmethyl-adamantane 1,3,5,7-Tetrmethyl-adamantane 1687-36-1 C14H24
4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one 4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one 34523-34-7 C8H9NO2
3-(4,6-diamino-5-((methoxycarbonyl)amino)pyrimidin-2-yl)-5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine 7-oxide 3-(4,6-diamino-5-((methoxycarbonyl)amino)pyrimidin-2-yl)-5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine 7-oxide
Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate 121659-86-7 C20H16FNO2
Silodosin Silodosin 160970-64-9 C25H32F3N3O4
(3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE (3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE 76646-91-8 C8H9Br2NO5S
Vonoprazan Trimer Impurity Vonoprazan Trimer Impurity
(S)-Citalopram N-Oxide (S)-Citalopram N-Oxide 917482-45-2 C20H21FN2O2
7-Epi-docetaxel (Docetaxel Impurity C) 7-Epi-docetaxel (Docetaxel Impurity C) 153381-68-1 C43H53NO14
Amido Methyl Meloxicam (Meloxicam Impurity) Amido Methyl Meloxicam (Meloxicam Impurity) 892395-41-4 C15H15N3O4S2
4-Nitrofluorobenzol 4-Nitrofluorobenzol 352-15-8 C6H4FNO
propyl[2,6'-bi-1H-benzimidazol]-1'-yl]methyl]- propyl[2,6'-bi-1H-benzimidazol]-1'-yl]methyl]- 144702-27-2 C33H29N5
4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid 4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid 72570-70-8 C13H19NO4
Fluvoxamino Acid Fluvoxamino Acid 192876-02-1 C14H19F3N2O2
Fluvastatin N-Ethyl Sodium Salt (Fluvastatin Impurity) Fluvastatin N-Ethyl Sodium Salt (Fluvastatin Impurity) 93936-64-2 C23H23FNNaO4
1-(4-hydroxy-2-methoxyphenyl)ethanone 1-(4-hydroxy-2-methoxyphenyl)ethanone 493-33-4 C9H10O3
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