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### Kev Tshawb Fawb Txog Kev Tshawb Fawb Txog Indada Hom Khoom Zoo Roj Testosterone Acetate 75

Stada yog lub tuam txhab German nto moo uas tsom mus rau kev txhim kho tshuaj thiab cov khoom lag luam ntawm cov tshuaj Testosterone (HRT) Cov kab mob . Cov lus no yuav pom zoo cov yam ntxwv ntawm cov khoom lag luam no, suav nrog nws cov tshuaj lom neeg, cov chaw kho mob thiab tswj hwm zoo}

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### 1. Kev Tshuaj Thiab Tshuaj Siv Tshuaj Ntawm Testterosterone Acetate 75

#### 1.}, tshuaj lom neeg thiab nomenclature **

- ** Molecular cov mis **: C₂₂h₃₂o₃

- **} hydroxyandrost {{2}-3- ib qho acetate

- ** Molecular hnyav **: 344.49 g / mol

- ** ESterification Cwj Pwm **: Testosterone molecules ua ke nrog acetate ntawm lub lipid-soluble esterified derivative, uas ncua sij hawm ntawm cov tshuaj thiab txhim kho kev ruaj khov.

#### 2.} ** Cim ob qho cim cov yam ntxwv **

- ** RELDECH CRANCIALISMIAN **: Tom qab txhaj tshuaj, cov roj tsheb maj mam tso cov tshuaj, thiab cov ntshav ncig ua si .

- ** ib nrab-lub neej **: Tus luv tshaj Ester Saw Tsim ntawm acetate ua nws ib nrab-hnub1-2}}}}}}}}}}}}}}}}}}}}}}}}} 8}}

- ** Bioavailability **: Qhov kev txhaj tshuaj ntawm intramuscular ntawm intramuscular txhaj yog ze rau 95%, siab dua li qhov ncauj lossis hloov chaw npaj siab.

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### 2. lub cev thiab tshuaj lom neeg thiab cov yam ntxwv tsim tau

#### 1.} ** Kev xaiv thiab ua kom zoo ntawm cov roj nqa roj **

- ** Cov roj roj ntau dua **: Kev pham siab purity sesame roj lossis cov roj catorts los xyuas kom ntseeg tau cov tshuaj thiab txo kev txob txob ntawm kev txhaj tshuaj .

- ** Viscosity cultiv **: Lub viscosity ntau yam ntawm cov roj yog tswj hwm hauv {1} Kev sib nqus ntawm cov nyhuv (25 kev sib tw ua yeeb yam tso tawm {}

- ** Density **: Txog {{1} g / cm³, ze rau qhov kev pheej hmoo ntawm kev tso nyiaj hauv zos tom qab txhaj .

#### 2.} ** Stability Incameters **

- ** Qhov kub kom tiv thaiv **: Nws tuaj yeem ua kom ruaj khov rau ntawm {{} {degree rau kev ua tau zoo (xws li thaum lub sij hawm thauj).

- ** Lub teeb rhiab heev **: Nws yuav tsum tau muab tso rau ntawm lub teeb, vim hais tias cov kev ua haujlwm estraviolet yuav ua rau cov kev ua feem ntawm tes testosterone free.

- ** PHI PHEEJ YOOJ YIM **: Tus nqi PH ntawm kev npaj yog tswj hwm ntawm tib neeg lub cev ib puag ncig thiab txo kev txhaj tshuaj mob.

#### 3.} ** solubility thiab incompatibility **

- ** Solubility **: Lub solubility rau hauv cov roj yog ntau dua los yog sib npaug ntawm 75 mg / ml los ntseeg tau tias tsis muaj cov muaj tseeb nag lossis daus.

- ** "Tsis txhob sib xyaw nrog cov kev daws teeb meem zoo thiab cov kev daws teeb meem alkaline, uas tuaj yeem ua rau ESTEEER BLOture lossis roj theem sib cais .

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### 3.}}} cov khoom siv thiab cov khoom siv ntawm kev npaj

#### 1.} ** xim thiab pob tshab **

- ** Tus qauv xim **: Lub teeb daj rau Amber pob tshab roj, cov xim sib txawv yog vim cov roj ntawm cov roj muaj teeb daj yog daj,

- ** Cob nrhiav kev yuav tsum tau ua **: lim los ntawm 0 {{{{}}}}}}}}}}}}}}}}}}}}}}}} there μ there thatត្ត្ត់ that there there or or lossis turbidity.

#### 2. ** hnov tsw thiab kov **

- ** Oily muaj ntxhiab tsw ntxhiab tsw, tsis muaj kev npau suav tsw me, nyob rau hauv txoj kab nrog cov qauv rau cov qauv tshuaj kom zoo siab.

- ** K KOV TEEV NRHIAV Nyem **: Kev txhaj tshuaj thiab kev txhaj tshuaj tiv thaiv qis dua lossis sib npaug nrog 3 {{3 n (kuaj nrog 23 pob).

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### 4.}}} analysis analysis analysis analysis analysis analysis of ntawm Cov Qauv Cov Khoom Muag

#### 1.} ** Purity thiab tsis txaus ntseeg **

- ** Cov khoom lag luam nyoos **<0.1%.

- ** Txheej txheem ntau lawm **: Supercritical kev rho tawm tshuab yog siv los ntxuav cov roj hauv paus, thiab cov khoom seem (xws li hexane) yog tsawg dua 10.

#### 2.}} ** kho cov tshuaj tswj tau meej **

- ** FILLICATHENTORY **: Cov koob tshuaj yuam kev ntawm txhua tus 1 ML Cov Kws Ua Haujlwm Ua Ntej yog tsawg dua EP (European Pharmacopoe) txhaj tshuaj .

- ** Batch Kev sib txawv **: Cov tshuaj confentration sib txawv ntawm cov sib txawv yog kom tsawg dua 3% los ntawm HPLC-UV cov txheej txheem {}}}

#### 3.} ** Kev Ruaj Ntseg Kev Nyab Xeeb Tsim **

- ** antimicrobial xaiv **: Qee cov qauv muaj cov dej cawv benzyl (ntau dua lossis sib npaug ntawm cov tshuaj tua kab mob hauv zos.

- ** Kev tswj cov khoom xyaw rau cov roj hmab, cov ntim khoom siv bromobutyl roj hmab nres kom txo qis kev pheej hmoo ntawm cov rhiab heev.

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## 5. chaw kuaj mob thiab taw qhia

#### 1.} ** Cim qhov tseem ceeb **

- ** Txiv neej hypogonadism **: Hloov kev kho rau cov neeg mob uas muaj mob ntshav testosterone<300 ng/dL to improve sexual function, bone density and muscle mass.

- ** Poj niam Androgen Daiievic **: Kev kho cov tshuaj qis rau cov poj niam epruveopant rau cov poj niam postmenopausal (androgenization phiv tshuaj) .

- ** AIDS-ntsig txog kev tsis muaj txiaj ntsig wasting syndrome **: nce cov nqaij ntshiv cev thiab txo cov leeg nqaij catabolism .

#### 2.} ** Dosage Regimen Piv Txwv **

- ** Kev txhaj tshuaj qauv qauv **: {50-100}, kev txhaj tshuaj, kho raws li cov ntshav tes testosterone qib.

- ** Peak thiab trough **: Peak Ntshav Tshuaj yog mus txog 242 teev {{}}} .

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### 6. Zoo Tswj thiab Ua Raws

#### 1. ** Cim ** Cov Qauv Ntau Lawm **

- ** GMP daim ntawv pov thawj **: Ua raws li cov EU EU ema thiab Asmeskas FDA, thiab cov kab ntau lawm yog ISO 9001 lees paub.

- ** Kev ntsuas kev ruaj ntseg **: Kev ntsuas kev nrawm (40℃/ 75% kev ntsuas Rh, 6%) thiab 24% cov ntaub ntawv tiav .

#### 2. ** Txoj kev pom **

- ** Kev txiav txim siab cov ntsiab lus theem siab ua kua chromatography (RP-HPLC), C18, Kev Tshawb Nrhiav Wavelength 240 NM.

- ** Kev ua kom tsis muaj zog ": Lub davhlau tshav kub kom tsis muaj sij hawm (noo noo kev ua kom tsis muaj menyuam yaus, 15 feeb) ua ke nrog aseptic filling thev naus laus zis .

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### 7. sib piv nrog lwm cov testosterone esters

|-------------------|--------------------------|----------------------------|----------------------------|

| ** Lub sijhawm ua siab tshaj plaws lub sijhawm **|24 teev|48-72} teev|72-96} teev |

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### 8. cia thiab siv cov kev ceev faj

{{01.}}}} Xaiv cov neeg tuaj **: Khaws cia rau hauv qab no 25 degree, yuav ua rau cov roj stratification) .

{{02.}}}}} Nyem cov kev txhaj tshuaj **: Nws raug pom zoo kom siv cov chaw txhaj tshuaj

{{03.}}}} Cov Tshuaj Tiv Thaiv HEMATED **: PTA thiab Laiv Muaj Peev Xwm Los Tiv Thaiv Kev Pheej Hmoo Plethora thiab Prostate hyperplasia.

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### xaus

Stada Tus Testosterone Acetate 75 tau dhau los ua cov qauv kev lag luam luv luv thiab cov txheej txheem ua kom zoo nkauj tsis muaj txiaj ntsig thiab cov txheej txheem ua kom zoo dua qub Yav tom ntej, nrog rau kev txhim kho cov roj nplua nuj tshuaj, cov peev txheej zoo li cov txiaj ntsig zoo hauv kev kho lub luag haujlwm ntawm kev kho cov tshuaj hormones}